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U.S. Department of Health and Human Services

Regulatory Information

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2000 Chronological List of Petitions and Advisory Opinions

 To view actual documents, make a note of the docket number, go to regulations.gov and enter the docket number in the search box. You will then get everything associated with that docket number.

Interim Response is not a final decision on the petition.

January | February | March | April | May | June | July | August | September | October | November | December

Date Filed Docket # Name of Petitioner/Subject Matter Disposition
January      
01/04/2000 2000P-0090 Pentech Pharmaceuticals Inc/Determine Paxil Oral Capsules not withdrawn for safety reaso  
01/04/2000 2000P-0091 Mitchall G Clark/ANDA Suitability for Pamidronate Disodium Injection  
01/05/2000 2000P-0092 GensiaSicor Pharmaceuticals/ANDA Suitability for Thiotepa for Injection  
01/05/2000 1999P-5589 Ethicon, Inc./Reclassification of Absorbable Polydioxanone Surgical Suture  
01/05/2000 1999V-5588 Gulf World, Inc./Laser Light Show  
01/07/2000 2000P-0110 Merck & Co. Inc./Add finasteride to priority section of "the List"  
01/07/2000 2000V-0111 Active Production & Design/Laser Light Show (Mobolazer ML10-200,ML-300,ML10-300W,  
01/07/2000 2000V-0112 Creative Artists Productions/Laser Light SHow  
01/10/2000 2000P-0117 Phoenix Scientific Inc/ANADA Suitability for Lincomycin-Spectinomycin Water Soluble  
01/10/2000 2000V-0135 Peppermill Casino/Variance Laserium CSLP Projector  
01/11/2000 2000P-0177 Robert Cohen/Request that FDA not Approve Upjohn's Bovine Growth Hormone  
01/14/2000 2000H-0211 Candyman Productions/Laser Light Show  
01/18/2000 2000P-0219 Andrx Pharmaceuticals Inc./Verapamil Hydrochloride Extended-Release Tablets  
01/27/2000 2000V-0310 Museum of Science and History/Laser Light Show  
01/27/2000 2000V-0354 Chabot Observatory & Science Center/Laser Light Show,Omniscan Laser Projection System,2000 Serie
 
01/28/2000 2000P-0442 Ludlow Technical Products/Variance from Perf Std for Electrode Lead Wires & Patient Ca  
01/31/2000 2000A-0355 Marcode/Industrial Marking Equipment Regarding Food Packing  
01/31/2000 2000V-0353 The Shops at Sunset Place/Laser Light Show  
Top      
February      
02/01/2000 2000P-0443 Pace Medical Inc/Exempt Model 4220 Sterile Disposable Surgical Extension Cabe  
02/03/2000 2000P-0425 Mead Johnson/To amend 21 CFR 107 Subpart B,labeling of infant formulas  
02/03/2000 1999P-1589 Roxane Laboratories, Inc/Stay effective date of approval for NDA 20-932 Roxicodone  
02/04/2000 2000P-0444 Phoenix Scientific Inc/ANADA Suitability for spectinomycin sterile solution  
02/04/2000 1998N-0044 Nutraceutical Corporation/Effect of dietary supplement on structure/function of body  
02/04/2000 2000P-0499 Apotex Inc/Review/Act on SKB '132 Form C & '423 Form A patent for NDA20  
02/07/2000 2000N-0506 Grocery Manufacturers of America/Safety Issues Associated With Dietary Supplements  
02/07/2000 2000P-0497 Baxter Healthcare Corporation/Exemption for the Baxter Volumetric Catheters  
02/07/2000 2000P-0498 Baxter Healthcare Corporation/Exempt Swan-Ganz Pacing Catheters and Probes  
02/07/2000 2000V-0496 Advanced Lighting & Production Services/Laser Light Show  
02/07/2000 1998N-0044 Grocery Manufacturers of America/Effect of dietary supplement on structure/function of body  
02/07/2000 1998N-0044 American Herbal Products Association/Effect of dietary supplement on structure/function of body  
02/07/2000 1998N-0044 CRN & CHPA/Effect of dietary supplement on structure/function of body  
02/07/2000 1998N-0044 CRN & CHPA/Effect of dietary supplement on structure/function of body  
02/07/2000 1998N-0044 McNeil Consumer Healthcare/Effect of dietary supplement on structure/function of body  
02/10/2000 2000V-0570 Pulse Laser Productions,LLC/Laser Light Show  
02/10/2000 2000V-0576 Event FX/Laser Light Show Mobolazer ML10-250,ML10-300,ML10-300W,ML100  
02/11/2000 2000P-0585 Lachman Consultant Services, Inc./Prozac (Fluoxetine) Tablets Voluntarily Withdrawn  
02/11/2000 2000P-0586 Natl Cheese Inst,Grocery Mfg of America/Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz  
02/12/2000 2000P-0653 The James Madison Project/Amend the product insert &/or label for Anthrax Vaccive adso  
02/14/2000 2000V-0654 Daddy Rocks, Inc/Mobolazer ML10-200, ML10-300, ML10-300W, ML10-1000, ML10-2.5  
02/14/2000 2000P-0596 Phoenix Scientific, Inc,/ANADA consisting of different physical form of drug product  
02/15/2000 2000V-0610 Insight Technology Incorporated/Infrared Laser Aiming Light  
02/15/2000 2000V-0611 Insight Technology Incorporated/( Visible and IR Laser Aiming Module (LAM)  
02/15/2000 2000V-0612 Insight Technology Incorporated/Laser Aiming Device (AN/PAQ-4C)  
02/18/2000 2000P-0685 National Yogurt Association/Revise of Yogurt Standards  
02/22/2000 2000V-0724 Mac Shane Laser Art Productions/Laser Light Show, Laser Art Series  
02/24/2000 2000P-0787 Abbott Laboratories/Electrode Lead Wires/Patient Cables of 21 CFR part 898  
02/25/2000 2000V-0791 Preston Productions Inc./Laser Light Show  
02/28/2000 2000P-0804 Thomas G. Crouthamel, Sr./FD&C Yellow #5 & FD&C Blue #1 Labeling  
02/29/2000 2000P-0788 Advanced Neuromodulation Systems, Inc./Totally Implanted Spinal Cord Stimulator  
02/29/2000 2000V-0808 Extreme Dome Enterainment/Laser Light Show Entreme Dome- Centrar Starbeam CKO3  
Top      
March      
03/01/2000 2000P-0842 Thomas Blake, R.Ph./Zantac 75 Effervescent Tablets  
03/01/2000 2000V-0877 Science Museum of Minnesota/Laser Light Show  
03/01/2000 2000V-0878 Franklin Institute Science Museum/Laser Light Show  
03/02/2000 2000V-0893 The Lions Share Inc/Laser Light Show  
03/03/2000 2000P-0913 McDermott, Will & Emery/ANDA suitability for Albuterol Sulfate inhalation solution,  
03/07/2000 2000V-0980 Carnegie Science Center/Laser light show (Omniscan laser projection system)  
03/07/2000 2000V-1058 Tom Casey/Laser Light Show  
03/08/2000 2000P-0931 Perkin Elmer Wallac Inc./Wallac's Neonatal Biotinidase Kit, Models NB-1000, NB-4000  
03/09/2000 2000V-1035 Donald Pascual/Laser Light Show Mobolazer ML10-200,ML10-300,ML10-3000W  
03/10/2000 2000V-1059 Rick's Durty Harrys Entertainment Comple/Laser light show  
03/13/2000 2000P-1077 The Humane Society of the United States/Amend Current Reg Banning Sale of Small Turtles  
03/13/2000 2000P-1084 Public Citizen's Health Group/Diabetes Drugs Troglitazone,rosiglitazone,pioglitazone  
03/13/2000 2000P-1117 Med Mira Laboratories Inc./Reclassify QuickAir Choke Reliever, Model 59-001A  
03/13/2000 2000V-1076 GDM Event Services/Laser Light Show Mobolazer ML10-200,ML10-300,ML10-300W,ML100 Approved 06/01/2006
03/13/2000 2000P-1085 American Orthotic & Prosthetic Ass/Classify cranial helment in class I,exempt from premarket  
03/14/2000 2000P-1120 UroSurge/UroSurge Percutaneous SANS Device  
03/14/2000 2000V-1118 Millenium Dance Club/Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,)  
03/15/2000 2000V-1125 New Pacific Inc./Laser Light Show (Mobolazer ML10-200,ML10-300,ML10-300W,  
03/15/2000 2000V-1126 SSI Production Services, Inc./Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,  
03/15/2000 2000V-1127 South Florida Science Museum/Laser Light Show Approved 11/03/2006
03/16/2000 2000P-1199 Biovail Corporation/Approval of ANDAs for Extended-Release  
03/16/2000 2000V-1158 System Concepts/Laser Light Show(Mobolazer ML10-200,ML10-300,ML10-300W,  
03/17/2000 1978N-0036L C.B. Fleet Company, Inc./OTC Laxative  
03/22/2000 2000P-1210 Occupational Knowledge International/Restrict Sale of Coal Tar-Containing Products  
03/22/2000 2000P-1211 Center for Food Safety/Establish Mandatory Pre-Market Safety Testing for GE Foods  
03/23/2000 2000V-1222 The Amphitheater/Laser light show  
03/23/2000 2000P-1213 Ferring Pharmaceuticals/ANDA injectable formulation calcitonin salmon (caltine)  
03/24/2000 1988N-0258 U.S. Small Business Administration/Prescription Drug Marketing Act of 1987; Guideline  
03/24/2000 1992N-0297 U.S. Small Business Administration/Prescription Drug Marketing Act of 1987, Drug Amds of 1992  
03/29/2000 2000V-1221 Long Island Laser Work/Laser Light Show (Long Island Laser Work) Approved 05/06/2005
03/31/2000 2000P-1209 KaVo America Corporation/Laser Flurescence Caries Detection Device  
03/31/2000 2000P-1225 Equi Aid Products, Inc./ANADA Suitability for Ivermectin Liquid for Horses  
03/31/2000 1988N-0258 Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987; Guideline  
03/31/2000 1992N-0297 Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987, Drug Amds of 1992  
Top      
April      
04/03/2000 2000P-1227 Center for Science in the Public Interes/Amend Statements Made for Dietary Supplements  
04/06/2000 1975N-0183H HFD-001 to Intnat'l Lab Technology Corp/Health-Care Antiseptic Drug Products for OTC Human Use  
04/07/2000 2000P-1240 CPR Medical Products Inc/Variance from Perf Std for Electrode Lead Wires & Patient Ca  
04/07/2000 2000P-1243 Pharmaceutical Associates Inc./ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen  
04/07/2000 2000V-1232 Ballinger Music/Laser Light Show  
04/07/2000 2000V-1241 Maryland Science Center/Laser Light Show  
04/07/2000 2000V-1244 Light Source/Laser Light Show  
04/11/2000 2000P-1245 Lachman Consultant Services, inc./ANDA for Nizatidine Capsules, 75mg  
04/11/2000 2000V-1247 Lazer Wizardry/Laser Light Show Approved 10/02/2003; Approved 10/02/2003;Terminated 06/01/2005; Approved 07/20/2005; Approved 12/15/2006; Approved 06/05/2007
04/13/2000 2000P-1258 GE Marquette Medical Systems Inc et al/Standard for Electrode Lead Wires and Patient Cables  
04/14/2000 2000V-1259 See Factory/Laser Light Show  
04/14/2000 2000V-1260 American Music Co./Laser light show  
04/18/2000 2000V-1261 FluoroScan Imaging Systems, Inc./FluoroScan Premier mini C-Arm  
04/18/2000 1992N-0412 Raj Matkari/Debarment of Raj Matkari; Notice of Opportunity for Hearing  
04/19/2000 2000P-1263 Genelabs Technologies, Inc/Initiation of Procedure to Determine Whether DHEA is exclude  
04/20/2000 2000V-1264 GE Medical Systems OEC/Source-skin distance requirement of the performance standard  
04/21/2000 2000P-1265 Biosense Webster Inc/Performance standard for electrode lead wires & patient cabl  
04/25/2000 2000P-1270 King & Spalding/ANDA for combination oxycodone hydrochloride/acetaminophen  
04/26/2000 2000V-1272 Aggessive Sound Inc./Laser Light Show  
04/26/2000 1983P-0187 Associated Pharmacologists & Toxicologis/Refrain from Approval of Polyurethane Contraceptive Sponge
 
04/27/2000 2000N-0598 Grocery Manufacturers of America (GMA)/Dietary Supplement Health Claim/Implementation of Pearson De
 
04/27/2000 2000P-1271 King & Spalding/Oxycodone hydrochloirde/acetaminophen tablet 2.5mg/400mg;5.0  
04/27/2000 2000V-1273 Broadway Magic/Laser Light Show  
Top      
May      
05/02/2000 2000P-1279 Chattanooga Group Inc/Extend the Compliance Dates for Electrode Lead Wires and Pat  
05/02/2000 2000P-1280 Abbott Laboratories/Exempt Devices Classified as Total Triiodothyronine Test Sys  
05/02/2000 2000V-1281 La Curacao/Laser Light Show, LM 8 Projection System APPROVED 09/16/2003 Approved 9/16/2003;Terminated 8/17/2005
05/03/2000 2000V-1285 Mid South Laser Shows/Laser light show  
05/04/2000 2000A-1288 Daniel Kearns/Bioburden, Environmental Monitoring  
05/05/2000 2000P-1282 UrosMetrics/EROS-Clitoral Therapy Device  
05/05/2000 2000P-1284 Grocery Mfrs of America et al/General info for making claims ref about lack of use of food  
05/05/2000 2000P-1286 EP MedSystems, Inc./Performance standard for electrode lead wires & patient cabl  
05/08/2000 2000V-1287 Main Light Industries, Inc/Laser Light Show APPROVED 05/14/2004
05/08/2000 1999P-4613 Robert Cohen/Revoke the Regulation That Approved Posilac  
05/09/2000 2000P-1289 GensiaSicor Pharmaceuticals/Submission of supplement to abbreviated new drug application  
05/09/2000 2000P-1290 Prizm Medical, Inc./Performance standard for electrode lead wire & patient cable  
05/09/2000 2000P-1291 Pharmaceutical Assoc Inc/Opioid anagesic elixir drug product suitable under an ANDA  
05/10/2000 2000P-1292 Amrex-Zetron Inc/Performance Standard for Electrode Lead Wires & Patient Cabl  
05/11/2000 2000P-1275 Lipton/Health Claim: Vegetable oil sterol esters & coronary heart d  
05/11/2000 1998N-0044 Consumer Healthcare Products Assn/Effect of dietary supplement on structure/function of body  
05/12/2000 2000P-1295 Accelerated Care Plus/Performance Standard for Electrode Lead Wires & Patient Cabl  
05/12/2000 2000V-1293 Vision Digital Media/Laser light show  
05/12/2000 2000V-1294 J.A. Investments, Inc dba Lava Lanes of/Laser Light Show  
05/17/2000 2000P-1297 Arnall Golden & Gregory, LLP/Permit an OTC drug mfg to include "may contain" in label  
05/18/2000 2000V-1301 G World Productions/Laser Light Show  
05/18/2000 2000V-1302 Carnegie Science Center/Laser Light Show  
05/19/2000 2000P-1304 Boston Scientific EP Technologies/Variance from application of the performance standard  
05/22/2000 2000P-1308 Lachman Consultant Services, Inc./Methimazole tablets USP,15mg/20mg are suitable for ANDA  
05/22/2000 2000V-1310 Pegasus Productions/Laser Light Show Projector  
05/24/2000 2000P-1276 McNeil Consumer Healthcare/Health Claim: Plant stanol esters and heart disease  
05/24/2000 2000V-1312 Cox Chiropractic Associates, Inc./Variance to Performance Standard for Electrical Lead Wires  
05/25/2000 2000P-1297 Arnall Golden & Gregory, LLP/Permit an OTC drug mfg to include "may contain" in label  
05/30/2000 2000P-1322 State of New York,MD,MI,WY,OH,TN,CT,VT,M/Food Labeling and Allergen Contamination Control  
05/30/2000 2000P-1324 Mikart, Inc/Propoxyphene Napsylate/Acetaminophen 100 Mg/500mg  
05/30/2000 2000P-1330 University of Pennsylvania/Regulation approving the dosage approved for drug Propecia  
05/30/2000 2000V-1323 Allen Memorial Planetarium/Laser Light Show  
05/31/2000 2000P-1319 IOMED, Inc./Performance Standard for Electrode Lead Wires & Patient Cabl  
05/31/2000 2000P-1320 Allegiance Healthcare Corporation/Performance Standard for Electrode Lead Wires & Patient Cabl  
05/31/2000 2000P-1325 Aspirin Foundation of America Inc/Declare Tylenol Arthritis Extended Relief Misbranded  
Top      
June      
06/01/2000 2000N-0598 Durk Pearson and Sandy Shaw et al./Dietary Supplement Health Claim/Implementation of Pearson De  
06/01/2000 2000P-1326 American Seafood Distritutors Assoc/Crabmeat; Amendment of Common or Usual Name Regulation  
06/01/2000 2000P-1342 Phoenix Scientific, Inc./Minor change in a generic Pyrantel Pamoate Paste  
06/01/2000 2000V-1327 Adlaser Pty Ltd/Medi-laze Smart Laser Product  
06/05/2000 2000P-1329 Arnall Golden & Gregory, LLP./Permit dietary supplement manufacturer to include the phrase  
06/06/2000 2000V-1331 Silver Hammer of Nevada LLC./Laser Light Show  
06/07/2000 2000V-1337 Miner Mike's Inc./Laser Light Show  
06/08/2000 2000V-1333 Falls Park Sound and Light Show Inc./Laser Pro Projector  
06/08/2000 2000V-1334 J.A. Investments, Inc./Laser Light Show  
06/12/2000 2000V-1338 Instant Request Inc/Laser Light Show  
06/13/2000 2000P-0586 NCI, NAPA & GMA/Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz  
06/13/2000 2000P-1340 Able Laboratories, Inc./Withdrawn of ROWASA Suppositories  
06/13/2000 2000V-1339 Club Fusion/Laser Display Device  
06/15/2000 2000P-1343 E-Z-EM, Inc./Reclassify Barium Enema Retention Catheter to Class II  
06/19/2000 2000P-1349 St. Jude Medical/Variance for Electrode Lead Wires and Patient Cables  
06/19/2000 2000V-1356 Rock Capital Systems, Corp./Laser light show  
06/20/2000 2000P-1352 GensiaSicor Pharmaceuticals/ANDA Suitability Petition Camiodarone Hydrochloride Injectio  
06/20/2000 2000V-1362 Powerhouse Pro/Laser light show  
06/21/2000 2000P-1355 Consumer Healthcare Products Assoc/Labeling requirements for dietary supplements/St.John's wort  
06/22/2000 2000P-1363 Iceberg Industries Corporation (Canada)/To Amend 21 CFR 165.110 to include a Standard of Identity  
06/22/2000 2000V-1358 L'ecole de Ballet Arts Studio/Laser light show  
06/23/2000 2000P-1365 Lachman Consultants Services Inc/ANDA be submitted for Fluoxetine Tablets/40 mg  
06/23/2000 2000P-1419 Lachman Consultant Services Inc/ANDA for Gabapentin Tablets 100 mg 300 mg and 400 mg  
06/27/2000 2000P-1369 CSPI/Prohibit Making an Unapproved Health Claim  
06/27/2000 2000P-1370 Medeva Pharmaceuticals, Inc/ANDA for generic verions of Zaroxolyn Tablets(metolazone DENIED 07/30/2003 Withdrawn 7/30/2003
06/27/2000 2000P-1371 IOMED,Inc/Performance Standard for Electrode Lead Wires and Patient  
06/28/2000 2000P-1372 Allegiance Healthcare Corporation/Performance Standard for Electrode Lead Wires & Patient Cabl  
06/28/2000 2000P-1375 Lachman Consultant Services, inc./ANDA for Methimazole Tablets USP,20mg  
06/28/2000 2000V-1376 Mars 2112/Laser Light Show LM-10 Projection systems/spectra physics  
06/28/2000 2000V-1377 Mighty Ducks Hocky Club, Inc./Laser Light Show(2) LM-10 Micro Yag Projection systems Approved 03/20/2006
06/28/2000 2000V-1381 Daddy Rocks Inc/Laser Light Show  
06/29/2000 2000P-0787 Abbott Laboratories/Electrode Lead Wires/Patient Cables of 21 CFR part 898  
06/30/2000 2000P-1378 CTFA/Cosmetic Products Containing Alpha Hydroxy Acids  
Top      
July      
07/03/2000 2000V-1382 Electronic Services Agency/AIG Limelight 200 & 45 Class IIIB Laser Diode Infrared Illum  
07/06/2000 2000P-1397 The Weinberg Group Inc/Cefaclor Chewable Tablets 500mg ANDA Suitability  
07/13/2000 2000V-1398 Micro Dot L.L.C./Laser light show  
07/14/2000 2000P-1406 Compressed Gas Assn/Nat Welding Supply/Stay Presenting, publishing promulgating "Fresh Air" Speeche  
07/14/2000 2000V-1405 Bon Secours South Country Heart Center/Telemetry transmitter cable  
07/17/2000 2000P-1243 Pharmaceutical Assoc Inc (PAI)/ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen Denied 05/07/2001
07/18/2000 2000P-1411 CSPI/Set a regulatory limit for methylmercury in seafood  
07/18/2000 2000V-1410 B. E. Meyers & Co., Inc./Class IIIb requirements for the IZLID Series laser Products  
07/18/2000 2000V-1417 Biolase Technology, Inc./Twilite Dental Diode Laser  
07/19/2000 2000V-1421 Club M.K./Laser Light Show  
07/20/2000 2000V-1420 Deceptikon Visuals/Laser Light Show  
07/20/2000 2000P-1422 Yamanouchi Pharma Tecnologies Inc./Suitability Petition (OTC),Famotidine Orally Disintegrating  
07/21/2000 2000V-1423 Super Bowl/Laser Light Show  
07/26/2000 2000V-1429 Laser Wizardry/Laser Light Show  
07/26/2000 2000V-1430 Surround Design Accociates/Laser Light Show  
Top      
August      
08/01/2000 2000P-1431 Pharmaceuitcal Associates, Inc./ANDA for elixir containing 10mg hydrocodone bitartrate/650mg  
08/02/2000 2000P-1432 Paul Dowhal/Pregnancy Warning Language on OTC Nicotine Products  
08/03/2000 2000P-1433 Yamanouchi Pharma Technologies, Inc./ANDA for OTC drug product Famotidine orally disintegrating t  
08/04/2000 2000V-1438 Randy Johnson & Assoc/Laser Light Show  
08/10/2000 2000P-1443 Zenith Goldline Pharmaceuticals/Stay against approval of Alendronate Sodium Tablets ANSWER 07/31/2003 answers PSA1 found in the docket
08/10/2000 2000V-1442 Yamagata Studio/Laser Light Show  
08/11/2000 2000P-1445 Zenith Goldline Pharmaceuticals/Paragraph IV ANDAs/180-Day Exclusivity Purporses ANSWER 07/31/2003
08/11/2000 2000P-1446 Teva Pharmaceuticals USA/Mylan Nifedipine extented-release tablets 30mg  
08/11/2000 2000V-1450 Celebration Park/Laser Light Show  
08/14/2000 2000P-1452 Cook Imaging Corporation/Supplement to Iopamidol Injection  
08/14/2000 2000V-1453 Disneyland Resort/Laser Light Show (Golden Dreams Laser Special Effects) Approved 06/08/2005; Termination date 12/21/2008
08/14/2000 2000V-1454 E-3/Laser Light Show, Mobolazer ML10-200,ML10-300,ML10-300W,  
08/16/2000 2000V-1459 Burning Man/Laser Light Show  
08/17/2000 2000P-1462 Lachman Consultant Services Inc./Extend Phenytoin Sodium Capsules  
08/17/2000 2000V-1461 DJ Distributors/Laser Light Show,ML10-200,ML10-300,ML10-300W,ML10-1.OG,  
08/17/2000 2000V-1464 Candyman Productions/Laser Light Show  
08/18/2000 2000P-1466 Pfizer, Inc./Non-Approvable Letters for Neurontin Withdrawn 02/08/2006
08/18/2000 2000V-1465 Family Bowling Center/Laser Light Show  
08/18/2000 2000V-1473 Steve Skrien/Laser Light Show  
08/22/2000 2000P-1265 Biosense Webster Inc/Performance standard for electrode lead wires & patient cabl  
08/22/2000 2000P-1468 Lachman Consultant Services, Inc./ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m  
08/22/2000 2000V-1469 ZooBar,Inc/Laser Light Show  
08/23/2000 2000P-1470 Baxter Healthcare Corporation/ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino Acid)  
08/23/2000 2000P-1471 GensiaSicor Pharmaceuticals/ANDA Suitability Petition Propofol Injectable Emulsion 2%  
08/23/2000 2000P-1472 Braintree Lab Inc/Over-the-counter sodium phosphate bowel preparation products  
08/23/2000 2000V-1476 My Generation/Laser light show  
08/23/2000 2000V-1477 Audio Line, Inc./Laser Light Show  
08/23/2000 2000V-1478 DJ Brat/Laser light show  
08/28/2000 2000V-1479 Dimension Seven/Laser Light Show  
08/28/2000 2000V-1480 Dino Quiroz/Laser Light Show  
08/28/2000 2000V-1481 Christopher Todd Aasen/Laser Light Show  
08/28/2000 1975N-0183H Woodward Laboratories, Inc./Health-Care Antiseptic Drug Products for OTC Human Use  
08/29/2000 2000P-1486 Equi Aid Products, Inc/ANADA Suitability Petition for a Generic Oral Ivermectin  
08/29/2000 2000V-1490 The Mens Club of Dallas/Laser Light Show  
08/30/2000 2000P-1491 Kraft Foods, Inc./Amend Definition & Standard of Identy for Parmesan Cheese  
08/30/2000 2000V-1492 Red Line Inc./Laser Light Show  
Top      
September      
09/01/2000 2000P-1496 Lachman Consultant Services,Inc./Gulucophage (Metformin HCI) Tablets, 625 mg and 750mg,  
09/05/2000 2000P-1500 Arnall Golden & Gregory LLP/Allow Dietary Supple Mfg to list ingredients aphabetically  
09/06/2000 2000P-1499 Public Citizen/Remove alosetron (Lotronex) from the market Answered 02/12/2004
09/06/2000 2000P-1518 PD Regulatory Services Inc/ANDA Suitability for Leucovorin Calcium Injection 5mg/ML  
09/06/2000 1978N-0038 Ciba Specialty Chemicals Corporation/Sunscreen Drug Products  
09/08/2000 2000P-1329 Consumer Healthcare Products Assoc (CHPA/Permit dietary supplement manufacturer to include the phrase  
09/11/2000 2000P-1510 CTS Chemical Industries, LTD (Israel)/Establish safety of Echinacea extract as a GRAS pharmaceutic  
09/11/2000 2000V-1509 Crystal Night Club/Laser Light Show  
09/12/2000 2000P-1297 Consumer Healthcare Products Assoc (CHPA/Permit an OTC drug mfg to include "may contain" in label  
09/12/2000 2000V-1512 Steve White/Laser light show  
09/12/2000 2000V-1514 Mainstream Music/Laser Light Show  
09/15/2000 2000P-1519 Smart Drug Systems Inc/ANADA for a generic new animal drug/Heartgard chewable tblts  
09/19/2000 1999V-5521 Pyro Magic Inc., DBA Laser Pyro Shows/Laser Light Show, SpectraScan LitePipe LP2-X Mobolazer  
09/21/2000 2000P-1533 Cook MED Institute, Incorporated/PTCA Balloon Catheters (74LOX)  
09/22/2000 2000P-1535 Boston Scientific Corporation/Biopsy forceps covers/non-electric biopsy as Class I devices  
09/26/2000 2000V-1559 B. C. T. Entertainment/Laser display device  
09/27/2000 2000V-1544 Kira LLC/Laser Light Show  
09/28/2000 2000V-1546 Linden Laser Systems/Laser Light Show  
09/28/2000 2000V-1547 John Coodey/John Coodey Laser Light Show  
09/29/2000 2000P-1548 Lachman Consultant Services, Inc./Neoral Soft Gelatin Capsules  
09/29/2000 2000V-1552 Pittsburgh Penguins Hockey Club/Laser light show  
09/29/2000 2000V-1553 Metropolis Theater/Laser light show  
Top      
October      
10/02/2000 2000P-1550 Glaxo Wellcome/Approve ANDA for Cefuroxime Axetil Products  
10/02/2000 2000P-1551 Arnall Golden & Gregory, LLP/Determine an ANDA may be submitted for a propxphene Napsylat  
10/02/2000 2000V-1549 Bulldent Inc. dba Our Place/Laser Light Show Approved 10/31/2003; Terminates 10/26/2005
10/03/2000 2000P-1554 Baxter Healthcare Corp/Exempt pharmacy compounding systems/Class II devices from PM  
10/04/2000 2000P-1556 Hyman Phelps & McNamara PC/Policy regarding ANDA holder confidentiality  
10/10/2000 0/2000 Paul E. Knapp/Health Hazard of "Radial" Sunglasses  
10/12/2000 1999P-4053 Mark P. Grath, Esq./Sympathominetic Amine Phentermine  
10/13/2000 2000P-1564 Alcon Research LTD./Grant a temporary exemption for one packaging component  
10/16/2000 2000P-1568 Lachman Consultant Services Inc/ANDA Suitability Petition for Ursodiol Oral Suspension  
10/18/2000 2000P-1572 State of Alaska/Adopt Standard of Identity for Bottled Glacier Water,Blend  
10/20/2000 2000P-1574 Recip AB, c/o R & R Registrations/ANDA Suitability Petition for Potassium Lodide 65 mg Tablets  
10/20/2000 2000P-1577 GE OEC Medical Systems, Inc./Variance from source-skin distance requirement of perf. std.  
10/20/2000 2000V-1573 Deja Vu of Washington Park/Laser Display Device  
10/20/2000 2000V-1581 Club Europe/Laser light show  
10/23/2000 2000P-1578 Michael R. Harbut, MD,MPH/Safety of Med.Devices Mfg. with Silicone Catalyzed w/ Hexach  
10/23/2000 2000V-1576 Insight Technology Incorporated/AN/PEQ-2A, Target Pointer-Illuminator/Aiming Light Approved 10/20/06
10/23/2000 1976N-0052N Public Citizen's Health Research Group/OTC Nasal Decongestants  
10/23/2000 1981N-0022 Public Citizen's Health Research Group/OTC Weight Control Drug Products for Human Use  
10/24/2000 2000P-1580 Lachman Consultant Services Inc/Listed drug withdrawn from sale; Drug product not marketed  
10/25/2000 1995N-0304 American Herbal Products Assn et al/Ephedrine Alkaloids: Reports of Adverse Events; Availability  
10/30/2000 2000V-1588 T & B Productions/Laser Light Show  
10/30/2000 2000V-1589 Quickbeam Systems Inc./Laser Light Show  
10/30/2000 2000V-1590 Sound Advice/Laser Light Show  
10/31/2000 2000P-1594 Highland Vet-Pharma, LLC/ANADA for Invermectin  
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November      
11/03/2000 2000P-1600 SciReg, Inc./ANADA Suitability for Ivermectin  
11/03/2000 2000P-1603 American College of Obstetricians & Gyne/Rescind Any Contraindications For Use of Misoprostol In Preg  
11/06/2000 2000P-1602 New Jersey General Assembly/Remove Unapproved Children's Fluoride Supplements from Mkt  
11/06/2000 2000V-1605 Sam's Town Hotel and Casino/Laser Light Show  
11/06/2000 2000V-1606 U.S. Space and Rocket Center/Laser Light Show  
11/07/2000 2000P-1607 Chemically Associated Neurological Disor/Revoke Implantation of Silicone Gel-Filled Breast Implants  
11/08/2000 2000V-1614 Midwest Stereo/Laser Light Show  
11/09/2000 2000P-1623 American College of OB-GYN (ACOG)/WDL of letter issued regarding product Misoprostol  
11/09/2000 2000V-1619 Backwaters, Inc./Laser light show  
11/09/2000 2000V-1622 Opryland Hospitality & Attractions/Opryl/Laser light show  
11/09/2000 1998P-0623 Levin Fishbein Sedran & Berman/Revoke determination that TSRH Pedicle Spinal Screw System  
11/13/2000 2000P-1617 Ventro Corporation/Exemptions Requirements of 21 CFR E-commerce Products  
11/13/2000 2000V-1624 The Club at II Panino/Laser light show  
11/13/2000 1978N-0038 Playtex Products, Inc./Sunscreen Drug Products  
11/15/2000 2000P-1621 Lipomed, Inc./ANDA suitability for cladribine-lipomed 10 mg/5ml  
11/15/2000 2000V-1627 Gear Connection/Laser light show  
11/16/2000 2000V-1626 S L V/Laser Light Show  
11/20/2000 2000P-1628 Anthron Bethea/Insurance Matters Regarding Unemployment & Social Security  
11/22/2000 2000A-1635 Advocacy, Incorporated/Pharmacological Studies - Disability Antidiscrimination  
11/24/2000 1997N-0314 Jerome Stevens Pharmaceuticals Inc/Prescription Drug Products; Levothyroxine Sodium  
11/27/2000 2000V-1656 Russell C Davis Planetarium/Application for transfer of variance for laser light show  
11/29/2000 2000P-1641 Pharmaceutical Associates, Inc./ANDA Suitability for Combo Hydrocodone Bitartrate & Acetamin  
11/29/2000 2000V-1643 Wicked Angel Entertainment/Laser Light Show  
11/30/2000 2000P-1645 McKenna & Cuneo, L.L.P./ANDA for Mercaptopurine 100 mg Scored Oral Tablet  
11/30/2000 2000V-1644 Laser Billboard Corporation, Inc./Laser Light Show  
11/30/2000 2000V-1646 Eclipse/Laser Light Show  
11/30/2000 2000V-1653 Marathon Marketing, LLC/Laser light show  
Top      
December      
12/04/2000 2000P-1648 NeuroControl Corporation/Electrode Lead Wires and Patient Cables  
12/04/2000 2000V-1647 Lumatech Lighting/Laser Light Show  
12/05/2000 2000P-1668 CSPI/Action against mfrs&dists of garlic supplements misbranded  
12/06/2000 2000P-1655 HighlandVet-Pharma LLC/ANADA Application; Proposed product differ from appoved list  
12/06/2000 2000P-1657 Cintas Corp./Request for exemption to allow phrase "may contain" on conta  
12/06/2000 2000V-1654 Safety & Compliance Consulting/Laser Light Show  
12/12/2000 2000V-1667 TSI Incorporated/LS200 LaserSpeed Velocity Measurement System  
12/14/2000 2000V-1670 Pure Bar Room/Laser Light Show  
12/15/2000 2000P-1671 Pharmacists Planning Service, Inc./Patient Medicine Guides (MedGuides)/Cox-II & NSAID  
12/18/2000 2000V-1673 The DJ Store/Request for Laser Light Show  
12/19/2000 2000P-1675 Biosite Diagnostics, Incorporated/Triage B-Type Natriuetic Peptide (BNP) Test (K003475)  
12/19/2000 2000P-1676 Southwest Texas State University/Electrode Lead Wires and Patient Cables  
12/20/2000 2000P-1491 Sartori Foods Corporation ./Amend Definition & Standard of Identy for Parmesan Cheese  
12/20/2000 2000P-1687 Sartori Food Corp./Amend definition & standard of identity for parmesan cheese  
12/21/2000 2000P-1680 Protein Technologies International, Inc./Amending the Method of Calculating Protein Content  
12/22/2000 2000V-1685 Storm Theater Group at Mamdalay Bay/Laser Light Show Lasermedia  
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