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  1. Substantial Equivalence

Substantial Equivalence Marketing Orders Archive

 

Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)
Top Tobacco L.P. Real Menthol 3 oz Medium Bag Roll-Your-Own Tobacco 9/5/2017 SE0000169 EA0000169 FONSI0000169
Top Tobacco L.P. Real Silver 8 oz Large Bag Roll-Your-Own Tobacco 9/5/2017 SE0000171 EA0000171 FONSI0000171
Top Tobacco L.P. Top Turkish 0.6 oz Pouch Roll-Your-Own Tobacco 9/5/2017 SE0000187 EA0000187 FONSI0000187
Top Tobacco L.P. Top Turkish 6 oz Canister Roll-Your-Own Tobacco 9/5/2017 SE0000188 EA0000188 FONSI0000188
Top Tobacco L.P. Real Menthol 8 oz Large Bag Roll-Your-Own Tobacco 9/5/2017 SE0000197 EA0000197 FONSI0000197
Top Tobacco L.P. Real Full Flavor 8 oz Large Bag Roll-Your-Own Tobacco 9/5/2017 SE0000207 EA0000207 FONSI0000207
Top Tobacco L.P. Real Gold 3 oz Medium Bag Roll-Your-Own Tobacco 9/5/2017 SE0000230 EA0000230 FONSI0000230
Top Tobacco L.P. Real Full Flavor 3 oz Medium Bag Roll-Your-Own Tobacco 9/5/2017 SE0000231 EA0000231 FONSI0000231
Top Tobacco L.P. Real Gold 8 oz Large Bag Roll-Your-Own Tobacco 9/5/2017 SE0000244 EA0000244 FONSI0000244
Top Tobacco L.P. Real Silver 3 oz Medium Bag Roll-Your-Own Tobacco 9/5/2017 SE0000252 EA0000252 FONSI0000252
Republic Tobacco, LP High Card Gold 100 mm Roll-Your-Own Tobacco 9/22/2017 SE0014064 EA0014064 FONSI0014064
Swedish Match USA Longhorn Fine Cut Natural 34.02 g Smokeless Tobacco 9/25/2017 SE0000098 Categorical Exclusion Categorical Exclusion
Swedish Match USA Longhorn Long Cut Natural 34.02 g Smokeless Tobacco 9/25/2017 SE0000099 Categorical Exclusion Categorical Exclusion
Swedish Match USA Longhorn Long Cut Wintergreen 34.02 g Smokeless Tobacco 9/25/2017 SE0000100 Categorical Exclusion Categorical Exclusion
SE0000100
Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)
Republic Tobacco, LP Ventura Whites Roll-Your-Own Tobacco 8/11/2017 SE0011188 EA0011188 FONSI0011188
Republic Tobacco, LP High Card Regular 100mm Roll-Your-Own Tobacco 8/16/2017 SE0013916 EA0013916 FONSI0013916
Republic Tobacco, LP High Card Gold King Size Roll-Your-Own Tobacco 8/16/2017 SE0013917 EA0013917 FONSI0013917
Republic Tobacco, LP High Card Menthol King Size Roll-Your-Own Tobacco 8/16/2017 SE0013918 EA0013918 FONSI0013918
Republic Tobacco, LP High Card Regular King Size Roll-Your-Own Tobacco 8/16/2017 SE0013919 EA0013919 FONSI0013919
Republic Tobacco, LP Top Gold 100MM Roll-Your-Own Tobacco 8/16/2017 SE0013920 EA0013920 FONSI0013920
Republic Tobacco, LP Top Gold 100MM Roll-Your-Own Tobacco 8/16/2017 SE0013921 EA0013921 FONSI0013921
Republic Tobacco, LP Top Regular 100MM Roll-Your-Own Tobacco 8/16/2017 SE0013922 EA0013922 FONSI0013922
Republic Tobacco, LP Top Regular 100MM Roll-Your-Own Tobacco 8/16/2017 SE0013923 EA0013923 FONSI0013923
Republic Tobacco, LP Top Silver 100MM Roll-Your-Own Tobacco 8/16/2017 SE0013924 EA0013924 FONSI0013924
Republic Tobacco, LP Top Silver 100MM Roll-Your-Own Tobacco 8/16/2017 SE0013925 EA0013925 FONSI0013925
Republic Tobacco, LP Top King Size Roll-Your-Own Tobacco 8/17/2017 SE0011134 EA0011134 FONSI0011134
Republic Tobacco, LP Job Organic Hemp Single Wide Roll-Your-Own Tobacco 8/17/2017 SE0013890 EA0013890 FONSI0013890
Japan Tobacco International, U.S.A, Inc. Wave Menthol King Size Cigarette 8/25/2017 SE0013536 EA0013536 FONSI0013536
Japan Tobacco International, U.S.A, Inc. Wave Full Flavor King Size Cigarette 8/25/2017 SE0013537 EA0013537 FONSI0013537
Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)

Republic Tobacco, LP

Gambler Single Wide

Roll-Your-Own Tobacco

06/08/2017

SE0013713

EA0013713

FONSI0013713

Republic Tobacco, LP

Gambler Single Wide

Roll-Your-Own Tobacco

06/08/2017

SE0013715

EA0013715

FONSI0013715

Swedish Match North America, Inc.

Longhorn Long Cut Mint

Smokeless

06/14/2017

SE011055

EA0011055

FONSI0011055

Republic Tobacco, LP

Abadie 1-1/2 Size

Roll-Your-Own Tobacco

6/30/2017

SE0012908

EA0012908 EA0012908-Memo

FONSI0012908

Republic Tobacco, LP

JOB 1.5 Gold

Roll-Your-Own Tobacco

6/30/2017

SE0012912

EA0012912 EA0012912-Memo

FONSI0012912

Republic Tobacco, LP

TOP Standard

Roll-Your-Own Tobacco

6/30/2017

SE0012913

EA0012913 EA0012913-Memo

FONSI0012913

Republic Tobacco, LP

Zig-Zag 1 1/4 Size French Orange

Roll-Your-Own Tobacco

6/30/2017

SE0012914

EA0012914 EA0012914-Memo

FONSI0012914

Republic Tobacco, LP

Rolling Standard

Roll-Your-Own Tobacco

6/30/2017

SE0012915

EA0012915 EA0012915-Memo

FONSI0012915

Republic Tobacco, LP

Zig-Zag King Size

Roll-Your-Own Tobacco

6/30/2017

SE0012916

EA0012916 EA0012916-Memo

FONSI0012916

Republic Tobacco, LP

Ventura Whites

Roll-Your-Own Tobacco

6/30/2017

SE0012917

EA0012917 EA0012917-Memo

FONSI0012917

Republic Tobacco, LP

Zig-Zag Kutcorners Slow Burning

Roll-Your-Own Tobacco

6/30/2017

SE0012918

EA0012918 EA0012918-Memo

FONSI0012918

Republic Tobacco, LP

JOB 1.0 Silver

Roll-Your-Own Tobacco

6/30/2017

SE0012919

EA0012919 EA0012919-Memo

FONSI0012919

Republic Tobacco, LP

TOP 1-1/2 Size

Roll-Your-Own Tobacco

6/30/2017

SE0012920

EA0012920 EA0012920-Memo

FONSI0012920

Republic Tobacco, LP

OCB Organic Hemp King Size Slim

Roll-Your-Own Tobacco

6/30/2017

SE0012921

EA0012921 EA0012921-Memo

FONSI0012921

Republic Tobacco, LP

OCB Ungummed

Roll-Your-Own Tobacco

6/30/2017

SE0012922

EA0012922 EA0012922-Memo

FONSI0012922

Republic Tobacco, LP

OCB Yellow Cigarette Papers with Tips

Roll-Your-Own Tobacco

6/30/2017

SE0012923

EA0012923 EA0012923-Memo

FONSI0012923

Republic Tobacco, LP

Zig-Zag White

Roll-Your-Own Tobacco

6/30/2017

SE0012924

EA0012924 EA0012924-Memo

FONSI0012924

Republic Tobacco, LP

JOB 1.0 Gold

Roll-Your-Own Tobacco

6/30/2017

SE0012925

EA0012925 EA0012925-Memo

FONSI0012925

Republic Tobacco, LP

JOB Tribal King Size

Roll-Your-Own Tobacco

6/30/2017

SE0012926

EA0012926 EA0012926-Memo

FONSI0012926

Republic Tobacco, LP

OCB Organic Hemp Single Wide

Roll-Your-Own Tobacco

6/30/2017

SE0012927

EA0012927 EA0012927-Memo

FONSI0012927

Republic Tobacco, LP

OCB Slim Long Cigarette Papers with Tips

Roll-Your-Own Tobacco

6/30/2017

SE0012928

EA0012928 EA0012928-Memo

FONSI0012928

Republic Tobacco, LP

JOB Single Wide (White)

Roll-Your-Own Tobacco

6/30/2017

SE0012929

EA0012929 EA0012929-Memo

FONSI0012929

Republic Tobacco, LP

Abadie 1-1/4 Size

Roll-Your-Own Tobacco

6/30/2017

SE0012930

EA0012930 EA0012930-Memo

FONSI0012930

Republic Tobacco, LP

JOB Brown Double Wide

Roll-Your-Own Tobacco

6/30/2017

SE0012931

EA0012931 EA0012931-Memo

FONSI0012931

Republic Tobacco, LP

Abadie Single Width

Roll-Your-Own Tobacco

6/30/2017

SE0012932

EA0012932 EA0012932-Memo

FONSI0012932

Republic Tobacco, LP

OCD Organic Hemp 1-1/4 Size

Roll-Your-Own Tobacco

6/30/2017

SE0012933

EA0012933 EA0012933-Memo

FONSI0012933

Republic Tobacco, LP

JOB Brown 1-1/4

Roll-Your-Own Tobacco

6/30/2017

SE0012934

EA0012934 EA0012934-Memo

FONSI0012934

Republic Tobacco, LP

JOB Brown 1-1/2

Roll-Your-Own Tobacco

6/30/2017

SE0012935

EA0012935 EA0012935-Memo

FONSI0012935

Republic Tobacco, LP

JOB French White

Roll-Your-Own Tobacco

6/30/2017

SE0012936

EA0012936 EA0012936-Memo

FONSI0012936

Republic Tobacco, LP

JOB Double Wide Gold

Roll-Your-Own Tobacco

6/30/2017

SE0012938

EA0012938 EA0012938-Memo

FONSI0012938

Republic Tobacco, LP

JOB Cutcorners (White)

Roll-Your-Own Tobacco

6/30/2017

SE0012946

EA0012946 EA0012946-Memo

FONSI0012946

Republic Tobacco, LP

JOB 1-1/4 (Orange)

Roll-Your-Own Tobacco

6/30/2017

SE0012947

EA0012947 EA0012947-Memo

FONSI0012947

Republic Tobacco, LP

JOB 1-1/2 (White) 99 ¢

Roll-Your-Own Tobacco

6/30/2017

SE0012948

EA0012948 EA0012948-Memo

FONSI0012948

Republic Tobacco, LP

JOB 1.5 Slim Gold

Roll-Your-Own Tobacco

6/30/2017

SE0012949

EA0012949 EA0012949-Memo

FONSI0012949

Republic Tobacco, LP

JOB 1.5 Silver

Roll-Your-Own Tobacco

6/30/2017

SE0012950

EA0012950 EA0012950-Memo

FONSI0012950

Republic Tobacco, LP

JOB 1.25 Silver

Roll-Your-Own Tobacco

6/30/2017

SE0012951

EA0012951 EA0012951-Memo

FONSI0012951

Republic Tobacco, LP

JOB 1.25 Gold

Roll-Your-Own Tobacco

6/30/2017

SE0012952

EA0012952 EA0012952-Memo

FONSI0012952

Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)

Top Tobacco LP

Largo Sun Grown Natural 8 oz Bag

Roll-Your-Own Tobacco

05/22/2017

SE0007297

EA0007297

FONSI0007297

Top Tobacco LP

Largo Sun Grown Natural 0.35 oz Pouch

Roll-Your-Own Tobacco

05/22/2017

SE0007298

EA0007298

FONSI0007298

Top Tobacco LP

Largo Full Flavor 0.35 oz Pouch

Roll-Your-Own Tobacco

05/22/2017

SE0007299

EA0007299

FONSI0007299

Top Tobacco LP

Largo Gold 0.35 oz Pouch

Roll-Your-Own Tobacco

05/22/2017

SE0007300

EA0007300

FONSI0007300

Top Tobacco LP

Largo Sun Grown Natural 3 oz Bag

Roll-Your-Own Tobacco

05/22/2017

SE0007301

EA0007301

FONSI0007301

Top Tobacco LP

Largo Menthol 0.35 oz Pouch

Roll-Your-Own Tobacco

05/22/2017

SE0007302

EA0007302

FONSI0007302

Top Tobacco LP

4 Aces Turkish 3.5 oz Canister

Roll-Your-Own Tobacco

05/22/2017

SE0007303

EA0007303

FONSI0007303

Top Tobacco LP

4 Aces Turkish 0.35 oz Pouch

Roll-Your-Own Tobacco

05/22/2017

SE0007304

EA0007304

FONSI0007304

Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)

Swedish Match North America, Inc.

Longhorn Long Cut Straight

Smokeless  04/21/2017 SE0003404 Categorical Exclusion Categorical Exclusion
Republic Tobacco, LP  Top King Size Roll-Your-Own Tobacco  04/28/2017  SE0000271  Categorical Exclusion Categorical Exclusion
Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)

Swedish Match North America, Inc.

General Classic Blend Portion White Large

Smokeless

01/13/2017

SE00010528

FONSI0010528

Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary EA/Catex/NEPA Memo Finding of No Significant Impact (FONSI)

Republic Tobacco, LP

OCB NO. 1 Single Wide

Roll-Your-Own Tobacco

12/30/2016

SE0010302

EA0010302

FONSI0010302

Republic Tobacco, LP

OCB Slim

Roll-Your-Own Tobacco

12/30/2016

SE0010303

EA0010303

FONSI0010303

Republic Tobacco, LP

OCB Red 1 1/4

Roll-Your-Own Tobacco

12/30/2016

SE0010304

EA0010304

FONSI0010304

 
Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary Environmental Assessment (EA)/Catex Finding of No Significant Impact (FONSI)

Silverfoiltubes International, Inc.

Vera Cruz Nocturne King Size Slim

Roll-Your-Own Tobacco

05/05/2016

SE0002200

EA0002200

FONSI0002200

Silverfoiltubes International, Inc.

Vera Cruz Midnight King Size Slim

Roll-Your-Own Tobacco

05/05/2016

SE0002202

EA0002202

FONSI0002202

Silverfoiltubes International, Inc.

Vera Cruz Elegante King Size Slim

Roll-Your-Own Tobacco

05/05/2016

SE0002220

EA0002220

FONSI0002220

Republic Tobacco, LP

OCB NO. 1 Single Wide

Roll-Your-Own Tobacco

12/30/2016

SE0010302

EA0010302

FONSI0010302

Republic Tobacco, LP

OCB Slim

Roll-Your-Own Tobacco

12/30/2016

SE0010303

EA0010303

FONSI0010303

Republic Tobacco, LP

OCB Red 1 1/4

Roll-Your-Own Tobacco

12/30/2016

SE0010304

EA0010304

FONSI0010304

FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)

SE0012445

December

Decision Summary

Available from manufacturer

EA0012445

FONSI0012445

SE0012446

December

Decision Summary

Available from manufacturer

EA0012446

FONSI0012446

           

SE0012332

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012332

FONSI0012332

SE0012333

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012333

FONSI0012333

SE0012334

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012334

FONSI0012334

SE0012335

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012335

FONSI0012335

SE0012336

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012336

FONSI0012336

SE0012337

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012337

FONSI0012337

SE0012338

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012338

FONSI0012338

SE0012339

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012339

FONSI0012339

SE0012340

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012340

FONSI0012340

SE0012341

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012341

FONSI0012341

SE0012342

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012342

FONSI0012342

SE0012343

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012343

FONSI0012343

SE0012344

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012344

FONSI0012344

SE0012345

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012345

FONSI0012345

SE0012346

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012346

FONSI0012346

SE0012347

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012347

FONSI0012347

SE0012348

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012348

FONSI0012348

SE0012349

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012349

FONSI0012349

SE0012350

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012350

FONSI0012350

SE0012351

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012351

FONSI0012351

SE0012352

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012352

FONSI0012352

SE0012353

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012353

FONSI0012353

SE0012356

December

Decision Summary

 

Memorandum

Available from manufacturer

EA0012356

FONSI0012356

FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0010524 November Decision Summary Available from manufacturer EA0010524 FONSI0010524
SE0010525 November Decision Summary Available from manufacturer EA0010525 FONSI0010525
SE0010526 November Decision Summary Available from manufacturer EA0010526 FONSI0010526
SE0010532 November Decision Summary Available from manufacturer EA0010532 FONSI0010532
SE0010533 November Decision Summary Available from manufacturer EA0010533 FONSI0010533
FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0011286 October Decision Summary Available from manufacturer    
SE0011288 October Decision Summary Available from manufacturer    
SE0011292 October Decision Summary Available from manufacturer    
SE0011299 October Decision Summary Available from manufacturer    
SE0011301 October Decision Summary Available from manufacturer    
SE0011302 October Decision Summary Available from manufacturer    
SE0011303 October Decision Summary Available from manufacturer    
SE0011304 October Decision Summary Available from manufacturer    
SE0011307 October Decision Summary Available from manufacturer    
SE0011313 October Decision Summary Available from manufacturer    
SE0011315 October Decision Summary Available from manufacturer    
SE0011316 October Decision Summary Available from manufacturer    
SE0011317 October Decision Summary Available from manufacturer    
SE0011318 October Decision Summary Available from manufacturer    
SE0011319 October Decision Summary Available from manufacturer    
SE0011323 October Decision Summary Available from manufacturer    
SE0011325 October Decision Summary Available from manufacturer    
SE0011329 October Decision Summary Available from manufacturer    
SE0011330 October Decision Summary Available from manufacturer    
SE0011332 October Decision Summary Available from manufacturer    
SE0011334 October Decision Summary Available from manufacturer    
SE0011337 October Decision Summary Available from manufacturer    
SE0011339 October Decision Summary Available from manufacturer    
SE0011341 October Decision Summary Available from manufacturer    
SE0011342 October Decision Summary Available from manufacturer    
SE0011343 October Decision Summary Available from manufacturer    
SE0011344 October Decision Summary Available from manufacturer    
SE0011345 October Decision Summary Available from manufacturer    
SE0011346 October Decision Summary Available from manufacturer    
SE0011348 October Decision Summary Available from manufacturer    
SE0011349 October Decision Summary Available from manufacturer    
SE0011350 October Decision Summary Available from manufacturer    
SE0011351 October Decision Summary Available from manufacturer    
SE0011352 October Decision Summary Available from manufacturer    
SE0011353 October Decision Summary Available from manufacturer    
SE0011355 October Decision Summary Available from manufacturer    
SE0011358 October Decision Summary Available from manufacturer    
SE0011359 October Decision Summary Available from manufacturer    
SE0011360 October Decision Summary Available from manufacturer    
SE0011361 October Decision Summary Available from manufacturer    
SE0011364 October Decision Summary Available from manufacturer    
SE0011365 October Decision Summary Available from manufacturer    
SE0011366 October Decision Summary Available from manufacturer    
SE0011367 October Decision Summary Available from manufacturer    
SE0011368 October Decision Summary Available from manufacturer    
SE0011369 October Decision Summary Available from manufacturer    
SE0011370 October Decision Summary Available from manufacturer    
SE0011372 October Decision Summary Available from manufacturer    
SE0011374 October Decision Summary Available from manufacturer    
SE0011375 October Decision Summary Available from manufacturer    
SE0011376 October Decision Summary Available from manufacturer    
SE0011377 October Decision Summary Available from manufacturer    
SE0011380 October Decision Summary Available from manufacturer    
SE0011382 October Decision Summary Available from manufacturer    
SE0011387 October Decision Summary Available from manufacturer    
SE0011388 October Decision Summary Available from manufacturer    
SE0011389 October Decision Summary Available from manufacturer    
SE0011390 October Decision Summary Available from manufacturer    
SE0011391 October Decision Summary Available from manufacturer    
SE0011392 October Decision Summary Available from manufacturer    
SE0011394 October Decision Summary Available from manufacturer    
SE0011395 October Decision Summary Available from manufacturer    
SE0011396 October Decision Summary Available from manufacturer    
SE0011403 October Decision Summary Available from manufacturer    
SE0011404 October Decision Summary Available from manufacturer    
SE0011405 October Decision Summary Available from manufacturer    
SE0011406 October Decision Summary Available from manufacturer    
SE0011407 October Decision Summary Available from manufacturer    
SE0011410 October Decision Summary Available from manufacturer    
SE0011414 October Decision Summary Available from manufacturer    
SE0011418 October Decision Summary Available from manufacturer    
SE0011422 October Decision Summary Available from manufacturer    
SE0011475 October Decision Summary Available from manufacturer    
SE0011477 October Decision Summary Available from manufacturer    
SE0011481 October Decision Summary Available from manufacturer    
SE0011485 October Decision Summary Available from manufacturer    
SE0011488 October Decision Summary Available from manufacturer    
SE0011490 October Decision Summary Available from manufacturer    
SE0011491 October Decision Summary Available from manufacturer    
SE0011492 October Decision Summary Available from manufacturer    
SE0011493 October Decision Summary Available from manufacturer    
SE0011496 October Decision Summary Available from manufacturer    
SE0011502 October Decision Summary Available from manufacturer    
SE0011504 October Decision Summary Available from manufacturer    
SE0011505 October Decision Summary Available from manufacturer    
SE0011506 October Decision Summary Available from manufacturer    
SE0011507 October Decision Summary Available from manufacturer    
SE0011508 October Decision Summary Available from manufacturer    
SE0011511 October Decision Summary Available from manufacturer    
SE0011513 October Decision Summary Available from manufacturer    
SE0011517 October Decision Summary Available from manufacturer    
SE0011518 October Decision Summary Available from manufacturer    
SE0011520 October Decision Summary Available from manufacturer    
SE0011522 October Decision Summary Available from manufacturer    
SE0011524 October Decision Summary Available from manufacturer    
SE0011526 October Decision Summary Available from manufacturer    
SE0011528 October Decision Summary Available from manufacturer    
SE0011529 October Decision Summary Available from manufacturer    
SE0011530 October Decision Summary Available from manufacturer    
SE0011531 October Decision Summary Available from manufacturer    
SE0011532 October Decision Summary Available from manufacturer    
SE0011533 October Decision Summary Available from manufacturer    
SE0011535 October Decision Summary Available from manufacturer    
SE0011536 October Decision Summary Available from manufacturer    
SE0011537 October Decision Summary Available from manufacturer    
SE0011538 October Decision Summary Available from manufacturer    
SE0011539 October Decision Summary Available from manufacturer    
SE0011540 October Decision Summary Available from manufacturer    
SE0011542 October Decision Summary Available from manufacturer    
SE0011545 October Decision Summary Available from manufacturer    
SE0011546 October Decision Summary Available from manufacturer    
SE0011547 October Decision Summary Available from manufacturer    
SE0011548 October Decision Summary Available from manufacturer    
SE0011551 October Decision Summary Available from manufacturer    
SE0011552 October Decision Summary Available from manufacturer    
SE0011553 October Decision Summary Available from manufacturer    
SE0011554 October Decision Summary Available from manufacturer    
SE0011555 October Decision Summary Available from manufacturer    
SE0011556 October Decision Summary Available from manufacturer    
SE0011557 October Decision Summary Available from manufacturer    
SE0011559 October Decision Summary Available from manufacturer    
SE0011560 October Decision Summary Available from manufacturer    
SE0011561 October Decision Summary Available from manufacturer    
SE0011562 October Decision Summary Available from manufacturer    
SE0011564 October Decision Summary Available from manufacturer    
SE0011565 October Decision Summary Available from manufacturer    
SE0011567 October Decision Summary Available from manufacturer    
SE0011569 October Decision Summary Available from manufacturer    
SE0011570 October Decision Summary Available from manufacturer    
SE0011574 October Decision Summary Available from manufacturer    
SE0011575 October Decision Summary Available from manufacturer    
SE0011577 October Decision Summary Available from manufacturer    
SE0011578 October Decision Summary Available from manufacturer    
SE0011579 October Decision Summary Available from manufacturer    
SE0011581 October Decision Summary Available from manufacturer    
SE0011582 October Decision Summary Available from manufacturer    
SE0011583 October Decision Summary Available from manufacturer    
SE0011590 October Decision Summary Available from manufacturer    
SE0011591 October Decision Summary Available from manufacturer    
SE0011592 October Decision Summary Available from manufacturer    
SE0011593 October Decision Summary Available from manufacturer    
SE0011594 October Decision Summary Available from manufacturer    
SE0011595 October Decision Summary Available from manufacturer    
SE0011598 October Decision Summary Available from manufacturer    
SE0011602 October Decision Summary Available from manufacturer    
SE0011606 October Decision Summary Available from manufacturer    
SE0011610 October Decision Summary Available from manufacturer    
           
SE0010112 October Decision Summary Available from manufacturer EA0010112 FONSI0010112
SE0010959 October Decision Summary Available from manufacturer EA0010959

FONSI0010959

SE0010960 October Decision Summary Available from manufacturer EA0010960

FONIS0010960

SE0010961 October Decision Summary Available from manufacturer EA0010961

FONSI0010961

SE0010965 October Decision Summary Available from manufacturer EA0010965

FONSI0010965

SE0010966 October Decision Summary Available from manufacturer EA0010966

FONSI0010966

SE0010975 October Decision Summary Available from manufacturer EA0010975

FONSI0010975

SE0010976 October Decision Summary Available from manufacturer EA0010976

FONSI0010976

SE0010980 October Decision Summary Available from manufacturer EA0010980

FONSI0010980

SE0010981 October Decision Summary Available from manufacturer EA0010981

FONSI0010981

SE0010985 October Decision Summary Available from manufacturer EA0010985

FONSI0010985

SE0010986 October Decision Summary Available from manufacturer EA0010986

FONSI0010986

SE0010988 October Decision Summary Available from manufacturer EA0010988

FONSI0010988

SE0010989 October Decision Summary Available from manufacturer EA0010989

FONSI0010989

SE0010990 October Decision Summary Available from manufacturer EA0010990

FONSI0010990

SE0010991 October Decision Summary Available from manufacturer EA0010991

FONSI0010991

SE0010992 October Decision Summary Available from manufacturer EA0010992

FONSI0010992

SE0010993 October Decision Summary Available from manufacturer EA0010993

FONSI0010993

SE0010994 October Decision Summary Available from manufacturer EA0010994

FONSI0010994

SE0010995 October Decision Summary Available from manufacturer EA0010995

FONSI0010995

SE0010996 October Decision Summary Available from manufacturer EA0010996

FONSI0010996

SE0010997 October Decision Summary Available from manufacturer EA0010997

FONSI0010997

SE0011004 October Decision Summary Available from manufacturer EA0011004

FONSI0011004

FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)

SE0002424

September

Decision Summary

Available from manufacturer

   

SE0002425

September

Decision Summary

Available from manufacturer

   

SE0002426

September

Decision Summary

Available from manufacturer

   

SE0002427

September

Decision Summary

Available from manufacturer

   

SE0002428

September

Decision Summary

Available from manufacturer

   

SE0002429

September

Decision Summary

Available from manufacturer

   

SE0002430

September

Decision Summary

Available from manufacturer

   

SE0002431

September

Decision Summary

Available from manufacturer

   

SE0002432

September

Decision Summary

Available from manufacturer

   

SE0002433

September

Decision Summary

Available from manufacturer

   

SE0002434

September

Decision Summary

Available from manufacturer

   

SE0002435

September

Decision Summary

Available from manufacturer

   

SE0002436

September

Decision Summary

Available from manufacturer

   

SE0002437

September

Decision Summary

Available from manufacturer

   

SE0002438

September

Decision Summary

Available from manufacturer

   

SE0002439

September

Decision Summary

Available from manufacturer

   

SE0002440

September

Decision Summary

Available from manufacturer

   

SE0002441

September

Decision Summary

Available from manufacturer

   

SE0002442

September

Decision Summary

Available from manufacturer

   

SE0002443

September

Decision Summary

Available from manufacturer

   

SE0002444

September

Decision Summary

Available from manufacturer

   

SE0002445

September

Decision Summary

Available from manufacturer

   

SE0002446

September

Decision Summary

Available from manufacturer

   

SE0002447

September

Decision Summary

Available from manufacturer

   

SE0002448

September

Decision Summary

Available from manufacturer

   

SE0002449

September

Decision Summary

Available from manufacturer

   

SE0002450

September

Decision Summary

Available from manufacturer

   

SE0002451

September

Decision Summary

Available from manufacturer

   

SE0002452

September

Decision Summary

Available from manufacturer

   

SE0002453

September

Decision Summary

Available from manufacturer

   

SE0002454

September

Decision Summary

Available from manufacturer

   

SE0002455

September

Decision Summary

Available from manufacturer

   

SE0002456

September

Decision Summary

Available from manufacturer

   

SE0002457

September

Decision Summary

Available from manufacturer

   

SE0002458

September

Decision Summary

Available from manufacturer

   

SE0002459

September

Decision Summary

Available from manufacturer

   

SE0002460

September

Decision Summary

Available from manufacturer

   

SE0002462

September

Decision Summary

Available from manufacturer

   

SE0002464

September

Decision Summary

Available from manufacturer

   

SE0002465

September

Decision Summary

Available from manufacturer

   

SE0002466

September

Decision Summary

Available from manufacturer

   

SE0002467

September

Decision Summary

Available from manufacturer

   

SE0002468

September

Decision Summary

Available from manufacturer

   

SE0002469

September

Decision Summary

Available from manufacturer

   

SE0002470

September

Decision Summary

Available from manufacturer

   

SE0002471

September

Decision Summary

Available from manufacturer

   

SE0002472

September

Decision Summary

Available from manufacturer

   

SE0002473

September

Decision Summary

Available from manufacturer

   

SE0002474

September

Decision Summary

Available from manufacturer

   

SE0002479

September

Decision Summary

Available from manufacturer

   

SE0002480

September

Decision Summary

Available from manufacturer

   

SE0002481

September

Decision Summary

Available from manufacturer

   

SE0002482

September

Decision Summary

Available from manufacturer

   

SE0002484

September

Decision Summary

Available from manufacturer

   

SE0002495

September

Decision Summary

Available from manufacturer

   

SE0002496

September

Decision Summary

Available from manufacturer

   

SE0002497

September

Decision Summary

Available from manufacturer

   

SE0002498

September

Decision Summary

Available from manufacturer

   

SE0002499

September

Decision Summary

Available from manufacturer

   

SE0002500

September

Decision Summary

Available from manufacturer

   

SE0002501

September

Decision Summary

Available from manufacturer

   

SE0002502

September

Decision Summary

Available from manufacturer

   

SE0002503

September

Decision Summary

Available from manufacturer

   

SE0002504

September

Decision Summary

Available from manufacturer

   

SE0002505

September

Decision Summary

Available from manufacturer

   

SE0002506

September

Decision Summary

Available from manufacturer

   

SE0002507

September

Decision Summary

Available from manufacturer

   

SE0002508

September

Decision Summary

Available from manufacturer

   

SE0002509

September

Decision Summary

Available from manufacturer

   

SE0002510

September

Decision Summary

Available from manufacturer

   

SE0002511

September

Decision Summary

Available from manufacturer

   

SE0002513

September

Decision Summary

Available from manufacturer

   

SE0002514

September

Decision Summary

Available from manufacturer

   

SE0002515

September

Decision Summary

Available from manufacturer

   

SE0002516

September

Decision Summary

Available from manufacturer

   

SE0002517

September

Decision Summary

Available from manufacturer

   

SE0002518

September

Decision Summary

Available from manufacturer

   

SE0002520

September

Decision Summary

Available from manufacturer

   

SE0002521

September

Decision Summary

Available from manufacturer

   

SE0002522

September

Decision Summary

Available from manufacturer

   

SE0002523

September

Decision Summary

Available from manufacturer

   

SE0002524

September

Decision Summary

Available from manufacturer

   

SE0002525

September

Decision Summary

Available from manufacturer

   

SE0002526

September

Decision Summary

Available from manufacturer

   

SE0002527

September

Decision Summary

Available from manufacturer

   

SE0002528

September

Decision Summary

Available from manufacturer

   

SE0002529

September

Decision Summary

Available from manufacturer

   

SE0002530

September

Decision Summary

Available from manufacturer

   

SE0002531

September

Decision Summary

Available from manufacturer

   

SE0002532

September

Decision Summary

Available from manufacturer

   

SE0002533

September

Decision Summary

Available from manufacturer

   

SE0002534

September

Decision Summary

Available from manufacturer

   

SE0002541

September

Decision Summary

Available from manufacturer

   

SE0002542

September

Decision Summary

Available from manufacturer

   

SE0002543

September

Decision Summary

Available from manufacturer

   

SE0002544

September

Decision Summary

Available from manufacturer

   

SE0002545

September

Decision Summary

Available from manufacturer

   

SE0002546

September

Decision Summary

Available from manufacturer

   
FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0011287 June Decision Summary Available from manufacturer    
SE0011289 June Decision Summary Available from manufacturer    
SE0011291 June Decision Summary Available from manufacturer    
SE0011296 June Decision Summary Available from manufacturer    
SE0011298 June Decision Summary Available from manufacturer    
SE0011305 June Decision Summary Available from manufacturer    
SE0011308 June Decision Summary Available from manufacturer    
SE0011309 June Decision Summary Available from manufacturer    
SE0011310 June Decision Summary Available from manufacturer    
SE0011312 June Decision Summary Available from manufacturer    
SE0011321 June Decision Summary Available from manufacturer    
SE0011324 June Decision Summary Available from manufacturer    
SE0011326 June Decision Summary Available from manufacturer    
SE0011327 June Decision Summary Available from manufacturer    
SE0011328 June Decision Summary Available from manufacturer    
SE0011333 June Decision Summary Available from manufacturer    
SE0011338 June Decision Summary Available from manufacturer    
SE0011347 June Decision Summary Available from manufacturer    
SE0011354 June Decision Summary Available from manufacturer    
SE0011357 June Decision Summary Available from manufacturer    
SE0011362 June Decision Summary Available from manufacturer    
SE0011363 June Decision Summary Available from manufacturer    
SE0011373 June Decision Summary Available from manufacturer    
SE0011379 June Decision Summary Available from manufacturer    
SE0011381 June Decision Summary Available from manufacturer    
SE0011383 June Decision Summary Available from manufacturer    
SE0011384 June Decision Summary Available from manufacturer    
SE0011385 June Decision Summary Available from manufacturer    
SE0011386 June Decision Summary Available from manufacturer    
SE0011393 June Decision Summary Available from manufacturer    
SE0011397 June Decision Summary Available from manufacturer    
SE0011398 June Decision Summary Available from manufacturer    
SE0011399 June Decision Summary Available from manufacturer    
SE0011400 June Decision Summary Available from manufacturer    
SE0011401 June Decision Summary Available from manufacturer    
SE0011402 June Decision Summary Available from manufacturer    
SE0011408 June Decision Summary Available from manufacturer    
SE0011409 June Decision Summary Available from manufacturer    
SE0011412 June Decision Summary Available from manufacturer    
SE0011413 June Decision Summary Available from manufacturer    
SE0011415 June

Decision Summary

Decision Summary Addendum

Available from manufacturer    
SE0011416 June Decision Summary Available from manufacturer    
SE0011417 June Decision Summary Available from manufacturer    
SE0011419 June Decision Summary Available from manufacturer    
SE0011420 June Decision Summary Available from manufacturer    
SE0011421 June Decision Summary Available from manufacturer    
SE0011423 June Decision Summary Available from manufacturer    
SE0011468 June Decision Summary Available from manufacturer    
SE0011469 June Decision Summary Available from manufacturer    
SE0011471 June Decision Summary Available from manufacturer    
SE0011473 June Decision Summary Available from manufacturer    
SE0011474 June Decision Summary Available from manufacturer    
SE0011476 June Decision Summary Available from manufacturer    
SE0011478 June Decision Summary Available from manufacturer    
SE0011480 June Decision Summary Available from manufacturer    
SE0011487 June Decision Summary Available from manufacturer    
SE0011494 June Decision Summary Available from manufacturer    
SE0011497 June Decision Summary Available from manufacturer    
SE0011498 June Decision Summary Available from manufacturer    
SE0011499 June Decision Summary Available from manufacturer    
SE0011501 June Decision Summary Available from manufacturer    
SE0011509 June Decision Summary Available from manufacturer    
SE0011512 June Decision Summary Available from manufacturer    
SE0011514 June Decision Summary Available from manufacturer    
SE0011515 June Decision Summary Available from manufacturer    
SE0011516 June Decision Summary Available from manufacturer    
SE0011521 June Decision Summary Available from manufacturer    
SE0011525 June Decision Summary Available from manufacturer    
SE0011534 June Decision Summary Available from manufacturer    
SE0011541 June Decision Summary Available from manufacturer    
SE0011544 June Decision Summary Available from manufacturer    
SE0011549 June Decision Summary Available from manufacturer    
SE0011550 June Decision Summary Available from manufacturer    
SE0011566 June Decision Summary Available from manufacturer    
SE0011568 June Decision Summary Available from manufacturer    
SE0011571 June Decision Summary Available from manufacturer    
SE0011572 June Decision Summary Available from manufacturer    
SE0011573 June Decision Summary Available from manufacturer    
SE0011576 June Decision Summary Available from manufacturer    
SE0011580 June Decision Summary Available from manufacturer    
SE0011584 June Decision Summary Available from manufacturer    
SE0011585 June Decision Summary Available from manufacturer    
SE0011586 June Decision Summary Available from manufacturer    
SE0011587 June Decision Summary Available from manufacturer    
SE0011588 June Decision Summary Available from manufacturer    
SE0011589 June Decision Summary Available from manufacturer    
SE0011596 June Decision Summary Available from manufacturer    
SE0011597 June Decision Summary Available from manufacturer    
SE0011600 June Decision Summary Available from manufacturer    
SE0011601 June Decision Summary Available from manufacturer    
SE0011603 June Decision Summary Available from manufacturer    
SE0011604 June Decision Summary Available from manufacturer    
SE0011605 June Decision Summary Available from manufacturer    
SE0011607 June Decision Summary Available from manufacturer    
SE0011608 June Decision Summary Available from manufacturer    
SE0011609 June Decision Summary Available from manufacturer    
SE0011611 June Decision Summary Available from manufacturer    
SE0011656 June Decision Summary Available from manufacturer    
SE0011657 June Decision Summary Available from manufacturer    
SE0011659 June Decision Summary Available from manufacturer    
SE0011661 June Decision Summary Available from manufacturer    
SE0011662 June Decision Summary Available from manufacturer    
           
SE0009409

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009410

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009411

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009413

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009414

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009415

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009417

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009418

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009419

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009420

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009421

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009422

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009423

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009425

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009426

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009428

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009429

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009430

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009432

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009434

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009473

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009475

Rescission Letter
June Decision Summary Available from manufacturer    
SE0009476

Rescission Letter
June Decision Summary Available from manufacturer    
FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0002197 April Decision Summary Available from manufacturer    
SE0002204 April Decision Summary Available from manufacturer    
SE0002206 April Decision Summary Available from manufacturer    
SE0002218 April Decision Summary Available from manufacturer    
SE0002219 April Decision Summary Available from manufacturer    
SE0002224 April Decision Summary Available from manufacturer    
SE0002228 April Decision Summary Available from manufacturer    
SE0002229 April Decision Summary Available from manufacturer    
SE0002230 April Decision Summary Available from manufacturer    
SE0002235 April Decision Summary Available from manufacturer    
SE0002240 April Decision Summary Available from manufacturer    
SE0002241 April Decision Summary Available from manufacturer    
SE0002242 April Decision Summary Available from manufacturer    
SE0002246 April Decision Summary Available from manufacturer    
SE0002250 April Decision Summary Available from manufacturer    
SE0002252 April Decision Summary Available from manufacturer    
SE0002253 April Decision Summary Available from manufacturer    
SE0002254 April Decision Summary Available from manufacturer    
SE0002255 April Decision Summary Available from manufacturer    
SE0002257 April Decision Summary Available from manufacturer    
           
SE0010167 April Decision Summary Available from manufacturer    
SE0010168 April Decision Summary Available from manufacturer    
SE0010169 April Decision Summary Available from manufacturer    
SE0010170 April Decision Summary Available from manufacturer    
SE0010171 April Decision Summary Available from manufacturer    
FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0010365 March Decision Summary Available from manufacturer    
SE0010366 March Decision Summary Available from manufacturer    
SE0010367 March Decision Summary Available from manufacturer    
SE0010368 March Decision Summary Available from manufacturer    
SE0010369 March Decision Summary Available from manufacturer    
SE0010422 March Decision Summary Available from manufacturer    
FDA Order Letter Date FDA Decision Summary Health Summary Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0005838 February Decision Summary Available from manufacturer    
SE0005840 February Decision Summary Available from manufacturer    
SE0008136 February Decision Summary Available from manufacturer    
SE0008137 February Decision Summary Available from manufacturer    
SE0008138 February Decision Summary Available from manufacturer    
SE0008139 February Decision Summary Available from manufacturer    

 

FDA Order Letter Date FDA Decision Summary Health Summary  Environmental Assessment (EA) Finding of No Significant Impact (FONSI)
SE0004017 May Decision Summary SE0004017  Available from manufacturer     
SE0004018 May  Decision Summary SE0004018  Available from manufacturer     
SE0004019 May  Decision Summary SE0004019  Available from manufacturer     
SE0004020 May  Decision Summary SE0004020  Available from manufacturer     
           
SE0004606  June  Decision Summary SE0004606  Available from manufacturer      
SE0004607 June Decision Summary SE0004607 Available from manufacturer     
SE0004608 June Decision Summary SE0004608 Available from manufacturer     
SE0004609 June Decision Summary SE0004609 Available from manufacturer     
SE0004610 June Decision Summary SE0004610 Available from manufacturer     
           
SE0004021 June Decision Summary SE0004021 Available from manufacturer     
           
SE0003503 June Decision Summary SE0003503 Available from manufacturer  EA003503 FONSI3503
SE0003504 June Decision Summary SE0003504 Available from manufacturer  EA003504 FONSI3504
SE0003505 June Decision Summary SE0003505 Available from manufacturer  EA003505 FONSI3505
SE0003506 June Decision Summary SE0003506 Available from manufacturer  EA003506 FONSI3506
SE0003507 June Decision Summary SE0003507 Available from manufacturer  EA003507 FONSI3507
SE0003508 June Decision Summary SE0003508 Available from manufacturer  EA003508 FONSI3508
SE0003509 June Decision Summary SE0003509 Available from manufacturer  EA003509 FONSI3509
SE0003510 June Decision Summary SE0003510 Available from manufacturer  EA003510 FONSI3510
SE0003511 June Decision Summary SE0003511 Available from manufacturer  EA003511 FONSI3511
SE0003512 June Decision Summary SE0003512 Available from manufacturer  EA003512 FONSI3512
SE0003513 June Decision Summary SE0003513 Available from manufacturer  EA003513 FONSI3513
SE0003514 June Decision Summary SE0003514 Available from manufacturer  EA003514 FONSI3514
SE0003515 June Decision Summary SE0003515 Available from manufacturer  EA003515 FONSI3515
SE0003516 June Decision Summary SE0003516 Available from manufacturer  EA003516 FONSI3516
SE0003517 June Decision Summary SE0003517 Available from manufacturer  EA003517 FONSI3517
SE0003518 June Decision Summary SE0003518 Available from manufacturer  EA003518 FONSI3518
SE0003519 June Decision Summary SE0003519 Available from manufacturer  EA003519 FONSI3519
SE0003520 June Decision Summary SE0003520 Available from manufacturer  EA003520 FONSI3520
SE0003521 June Decision Summary SE0003521 Available from manufacturer  EA003521 FONSI3521
SE0003522 June Decision Summary SE0003522 Available from manufacturer  EA003522 FONSI3522
SE0003523 June Decision Summary SE0003523 Available from manufacturer  EA003523 FONSI3523
SE0003524 June Decision Summary SE0003524 Available from manufacturer  EA003524 FONSI3524
SE0010338 June Decision Summary SE0010338 Available from manufacturer  EA010338 FONSI0338
SE0010339 June Decision Summary SE0010339 Available from manufacturer  EA010339 FONSI0339
SE0010340 June Decision Summary SE0010340 Available from manufacturer  EA010340 FONSI0340
SE0010341 June Decision Summary SE0010341 Available from manufacturer  EA010341 FONSI0341
SE0010342 June Decision Summary SE0010342 Available from manufacturer  EA010342 FONSI0342
SE0010343 June Decision Summary SE0010343 Available from manufacturer  EA010343 FONSI0343
SE0010344 June Decision Summary SE0010344 Available from manufacturer  EA010344 FONSI0344
SE0010345 June Decision Summary SE0010345 Available from manufacturer  EA010345 FONSI0345
SE0010346 June Decision Summary SE0010346 Available from manufacturer  EA010346 FONSI0346
SE0010347 June Decision Summary SE0010347 Available from manufacturer  EA010347 FONSI0347
SE0010348 June Decision Summary SE0010348 Available from manufacturer  EA010348 FONSI0348
SE0010349 June Decision Summary SE0010349 Available from manufacturer  EA010349 FONSI0349
SE0010350 June Decision Summary SE0010350 Available from manufacturer  EA010350 FONSI0350
SE0010351 June Decision Summary SE0010351 Available from manufacturer  EA010351 FONSI0351
SE0010352 June Decision Summary SE0010352 Available from manufacturer  EA010352 FONSI0352
SE0010353 June Decision Summary SE0010353 Available from manufacturer  EA010353 FONSI0353
SE0010354 June Decision Summary SE0010354 Available from manufacturer  EA010354 FONSI0354
SE0010355 June Decision Summary SE0010355 Available from manufacturer  EA010355 FONSI0355
SE0010356 June Decision Summary SE0010356 Available from manufacturer  EA010356 FONSI0356
SE0010357 June Decision Summary SE0010357 Available from manufacturer  EA010357 FONSI0357
SE0010358 June Decision Summary SE0010358 Available from manufacturer  EA010358 FONSI0358
SE0010359 June Decision Summary SE0010359 Available from manufacturer  EA010359 FONSI0359
           
SE0004347 November Decision Summary SE0004347 Available from manufacturer     
SE0004349 November Decision Summary SE0004349 Available from manufacturer     
SE0004350 November Decision Summary SE0004350 Available from manufacturer     
SE0004351 November Decision Summary SE0004351 Available from manufacturer     
SE0004352 November Decision Summary SE0004352 Available from manufacturer     
SE0004353 November Decision Summary SE0004353 Available from manufacturer     
SE0004354 November Decision Summary SE0004354 Available from manufacturer     
SE0004356 November Decision Summary SE0004356 Available from manufacturer     
SE0004357 November Decision Summary SE0004357 Available from manufacturer     
SE0004358 November Decision Summary SE0004358 Available from manufacturer     
SE0004359 November Decision Summary SE0004359 Available from manufacturer     
SE0004360 November Decision Summary SE0004360 Available from manufacturer     
SE0004361 November Decision Summary SE0004361 Available from manufacturer     
SE0004362 November Decision Summary SE0004362 Available from manufacturer     
SE0004364 November Decision Summary SE0004364 Available from manufacturer     
SE0004366 November Decision Summary SE0004366 Available from manufacturer     
SE0004369 November Decision Summary SE0004369 Available from manufacturer     
SE0004370 November Decision Summary SE0004370 Available from manufacturer     
SE0004371 November Decision Summary SE0004371 Available from manufacturer     
SE0004372 November Decision Summary SE0004372 Available from manufacturer     
SE0004373 November Decision Summary SE0004373 Available from manufacturer     
SE0004374 November Decision Summary SE0004374 Available from manufacturer     
SE0004378 November Decision Summary SE0004378 Available from manufacturer     
SE0004379 November Decision Summary SE0004379 Available from manufacturer     
FDA Order Letter Date FDA Decision Summary Health Summary 
SE0003730 June Decision Summary SE0003730 Available from manufacturer
SE0003731 June  Decision Summary SE0003731 Available from manufacturer
       
SE0001697 September Decision Summary SE0001697 Available from manufacturer 
SE0001698 September  Decision Summary SE0001698 Available from manufacturer 
SE0003199 September  Decision Summary SE0003199 Available from manufacturer 
SE0003200 September  Decision Summary SE0003200 Available from manufacturer 
       
SE0003297 October

Decision Summary SE0003297

Decision Summary SE0003297 Addendum

Available from manufacturer 
SE0003298 October Decision Summary SE0003298 Available from manufacturer  
SE0003299 October Decision Summary SE0003299 Available from manufacturer  
       
SE0001762  November  Decision Summary SE0001762  Available from manufacturer   
SE0003525  November  Decision Summary SE0003525  Available from manufacturer   
SE0003526  November  Decision Summary SE0003526  Available from manufacturer   
SE0003528  November  Decision Summary SE0003528  Available from manufacturer   
SE0003529  November  Decision Summary SE0003529  Available from manufacturer   
SE0004386  November  Decision Summary SE0004386  Available from manufacturer   
SE0004387  November  Decision Summary SE0004387  Available from manufacturer   
SE0004388 November Decision Summary SE0004388 Available from manufacturer  

 * Unless otherwise noted, all Health Summaries are available from the manufacturer


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