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Dockets Management

Dockets Entered On February 8, 2007
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1999P-1340 Declared Eternity eau de Parfum Misbranded
2002P-0317 Recall Aspartame as a Neurotoxic Drug
2003N-0573 Draft Animal Cloning Risk Assessment
2005D-0091 Guidance for Industry on Waiver of User Fees for Fixed Dose Combination Products and Co-Packaged Products to Treat HIV
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
2006A-0318 Request for Advisory Opinion Concerning Orange Book Listing of Patents
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
2006E-0500 Patent Extension Application for Azilect (rasagiline mesylate), U.S. Patent No. 5,453,446
2006E-0501 Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
2006E-0502 Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
2006E-0532 Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
2006N-0036 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
2006P-0069 Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
2006P-0094 To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
2006P-0154 remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
2006P-0272 ANDA Suitability for 0.9% Sodium Chloride Injection
2006P-0306 Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
2006P-0307 To amend 21CFR 201.17 regarding expiration dates
2006P-0309 ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
2006P-0310 Compel the Agency to follow requirements of the Drug Listing Act of 1972
2006P-0311 Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
2006P-0450 Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
2007E-0002 Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
2007E-0009 Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
2007N-0016 Sentinel Network To Promote Medical Product Safety
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
2007V-0048 Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 18406 Perrigo Company of South Carolina Vol #: 168
LET 18407 Perrigo Company of South Carolina Vol #: 168
LET 18408 Perrigo Company of South Carolina Vol #: 168
LET 18409 Perrigo Company of South Carolina Vol #: 168
LET 18410 Perrigo Company of South Carolina Vol #: 168
LET 18411 Perrigo Company of South Carolina Vol #: 168
LET 18412 Perrigo Company of South Carolina Vol #: 168
LET 18413 Perrigo Company of South Carolina Vol #: 168
LET 18414 Perrigo Company of South Carolina Vol #: 168
LET 18415 Perrigo Company of South Carolina Vol #: 168
LET 18416 Perrigo Company of South Carolina Vol #: 168
LET 18417 Perrigo Company of South Carolina Vol #: 168
LET 18418 Perrigo Company of South Carolina Vol #: 168
LET 18419 Perrigo Company of South Carolina Vol #: 168
LET 18420 Perrigo Company of South Carolina Vol #: 168
LET 18421 Perrigo Company of South Carolina Vol #: 168
LET 18422 Perrigo Company of South Carolina Vol #: 168
LET 18423 Perrigo Company of South Carolina Vol #: 168
LET 18424 Perrigo Company of South Carolina Vol #: 168
LET 18425 Perrigo Company of South Carolina Vol #: 168
LET 18426 Perrigo Company of South Carolina Vol #: 168
LET 18427 Perrigo Company of South Carolina Vol #: 168
LET 18428 Perrigo Company of South Carolina Vol #: 168
LET 18429 Perrigo Company of South Carolina Vol #: 168
LET 18430 CPharmax, Inc. Vol #: 168
LET 18431 CPharmax, Inc. Vol #: 168
LET 18432 JOL Management Vol #: 168
LET 18433 Herbalife International of America INC Vol #: 168
LET 18434 Barmensen Labs, LLC Vol #: 168
LET 18435 Barmensen Labs, LLC Vol #: 168
LET 18436 Barmensen Labs, LLC Vol #: 168
LET 18437 Novartis Nutrition Corporation Vol #: 168
LET 18438 Nature's Way Products, Inc. Vol #: 168
LET 18439 Nature's Way Products, Inc. Vol #: 168
LET 18440 Garden of Life, Inc. Vol #: 168
LET 18441 Garden of Life, Inc. Vol #: 168
LET 18442 Garden of Life, Inc. Vol #: 168
LET 18443 Garden of Life, Inc. Vol #: 168
LET 18444 Garden of Life, Inc. Vol #: 168
LET 18445 Garden of Life, Inc. Vol #: 168
LET 18446 Pharmavite LLC Vol #: 168
LET 18447 Beulah Land Corporation Vol #: 168
LET 18448 Harmonic Innerprizes Vol #: 168
LET 18449 Perrigo Company of South Carolina Vol #: 168
LET 18450 Perrigo Company of South Carolina Vol #: 168
LET 18451 Perrigo Company of South Carolina Vol #: 168
LET 18452 Perrigo Company of South Carolina Vol #: 168
LET 18453 Perrigo Company of South Carolina Vol #: 168
LET 18454 Perrigo Company of South Carolina Vol #: 168
LET 18455 Perrigo Company of South Carolina Vol #: 168
LET 18456 Perrigo Company of South Carolina Vol #: 168
LET 18457 Perrigo Company of South Carolina Vol #: 168
LET 18458 Valeant Pharmaceuticals International Vol #: 168
LET 18459 The Origin Foods SDN BHD Vol #: 168
1999P-1340 Declared Eternity eau de Parfum Misbranded
EMC 669 J. Neal Vol #: 24
2002P-0317 Recall Aspartame as a Neurotoxic Drug
EMC 759 J. Bowen Vol #: 10
EMC 760 Mission Possible International Vol #: 10
EMC 761 Mission Possible International Vol #: 10
EMC 762 Mission Possible International Vol #: 10
2003N-0573 Draft Animal Cloning Risk Assessment
EMC 106 A. Rademacher Vol #: 5
2005D-0091 Guidance for Industry on Waiver of User Fees for Fixed Dose Combination Products and Co-Packaged Products to Treat HIV
GDL 2 Guidance Vol #: 1
NAD 2 FDA Vol #: 1
2005N-0279 Food Labeling; Gluten-Free Labeling of Foods
EMC 309 P. Faison Vol #: 32
EMC 310 A. Cox Vol #: 32
EREG 36 D. Patterson Vol #: 32
EREG 37 Celiac Vol #: 32
EREG 38 S. Dennis Vol #: 32
EREG 39 K. Zorica Vol #: 32
EREG 40 K. Hauser Vol #: 32
2005N-0373 Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants
EREG 3 J. Kelley Vol #: 7
2005N-0403 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs
C 85 Tech Air Vol #: 9
C 86 Scott-Gross Company Inc Vol #: 9
C 87 Pharmaceutical Technologies Services, Cardinal Health Vol #: 9
C 88 Indiana Oxygen Company Vol #: 9
C 89 Bristol-Myers Squibb Company Vol #: 9
C 90 Buchanan Ingersoll & Rooney PC Vol #: 9
C 91 Four Courners Welding & Gas Supply Vol #: 9
EC 26 NDC Working Group Vol #: 4
NEC 2 FDA Vol #: 8
2006A-0318 Request for Advisory Opinion Concerning Orange Book Listing of Patents
LET 1 FDA/CDER to Ropes & Gray LLP Vol #: 1
2006D-0383 Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases
AMD 1 Lasersmith Light Show Systems, LLC Vol #: 1
2006E-0500 Patent Extension Application for Azilect (rasagiline mesylate), U.S. Patent No. 5,453,446
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0501 Patent Extension Application for Gardasil (Quadravalent Human Papillomavirus Recombinant Vaccine), U.S. Patent No. 5,820,870
LET 2 FDA/CDER to U.S. Patent and Trademark Office Vol #: 1
2006E-0502 Patent Extension Application for Prezista (darunavir ethanolate), U.S. Patent No. 6,248,775
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2006E-0532 Patent Extension Application for Anthelios SX Daily Moisturizing Cream With Sunscreen, U.S. Patent No. 4,585,597
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 2
2006N-0036 Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosur
EMC 22 J. Richards Vol #: 1
EMC 23 M. Vol #: 1
EMC 24 A. Tenholder Vol #: 1
EMC 25 H. Craig Vol #: 1
EMC 26 A. Veggie Vol #: 1
EMC 27 R. Withers Vol #: 1
EMC 28 D. Edwards Vol #: 1
2006P-0069 Health Claim Petition: Soluble Fiber from Certain Foods and Coronary Heart Disease
EMC 1 B. Sachau Vol #: 2
2006P-0094 To undertake rulemaking to establish specific rules and regulations governing the definition of natural before a natural claim can be made on foods and beverages regulated by the FDA
C 5 The Sugan Association Vol #: 2
2006P-0154 remove from the market, the prescription version of Xenical (orlistat,Roche Pharmaceuticals)
PDN 1 FDA/CDER to Public Citizen Health Research Group, Case Western Reserve University Vol #: 1
2006P-0272 ANDA Suitability for 0.9% Sodium Chloride Injection
SUP 1 Beckloff Associates Vol #: 1
2006P-0306 Publish specific requirements for applications seeking approval to market therapeutically equivalent versions of insulin and human growth hormone
LET 1 FDA/CDER to State of Vermont, State of Wisconsin, Statement of Minnesota, State of Kansas Vol #: 1
2006P-0307 To amend 21CFR 201.17 regarding expiration dates
LET 2 Royal Medical Group Vol #: 1
2006P-0309 ANDA for ELOXATIN (oxaliplatin for injection) lyophilized powder for infusion, 50 mg and 100 mg vials
LET 1 FDA/CDER to Frommer, Lawrence & Haug LLP Vol #: 1
2006P-0310 Compel the Agency to follow requirements of the Drug Listing Act of 1972
LET 1 FDA/CDER to Peiser & Associates Inc Vol #: 1
2006P-0311 Investigate and take regulatory action to protect surgical patients from a potential significant safety risk in connection with Propofol Injectable Emulsion marketed by Bedford Laboratories
LET 1 FDA/CDER to Foley & Lardner LLP Vol #: 1
2006P-0450 Revoke approval of Allergan's supplemental NDA #21-257/S-013 for Lumigan (bimatoprost ophthalmic solution 0.03%) and deny Alcon's supplemental NDA for Travatan (travopr
C 2 Alcon Inc Vol #: 2
2007E-0002 Patent Extension Application for ELAPRASE (idursulfase), U.S. Patent No. 5,932,211
LET 3 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007E-0009 Patent Extension Application for Myozyme (Aglucosidase alfa), U.S. Patent No. 6,118,045
LET 2 FDA/CDER to the U.S. Patent and Trademark Office Vol #: 1
2007N-0016 Sentinel Network To Promote Medical Product Safety
EAPE 208 Stephenson, Hugo Vol #: 1
EAPE 209 Cheetham, Craig Vol #: 1
EAPE 210 Jones, Judith Vol #: 1
EAPE 211 Sholtes, Deborah Vol #: 1
EAPE 212 Trontell, Anne Vol #: 1
EAPE 213 Binzer, Margaret Vol #: 1
EAPE 214 Nourjah, Parivash Vol #: 1
EAPE 215 Smith, Scott Vol #: 1
EAPE 216 Villarraga, Marta Vol #: 1
EAPE 217 Randhawa, Gurvaneet Vol #: 1
EAPE 218 Robinson, Jill E. Vol #: 1
EAPE 219 Mason, Tanyss Vol #: 1
EAPE 220 Handrigan, Michael Vol #: 1
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
ACK 1 FDA/DDM to University of Florida Vol #: 1
CP 1 University of Florida Vol #: 1
2007V-0048 Laser Light Show
ACK 1 FDA /DDM to Baylor University Vol #: 1
VAR 1 Baylor University Vol #: 1

Page created on February 9, 2007 ue

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