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U.S. Department of Health and Human Services

Regulatory Information

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2002 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      
01/03/2002 2002P-0001 Biovail Corporation/Curb Abuses by Sponsors of ANDAs  
01/04/2002 2002P-0004 Ambi Pharmaceuticals, Inc./ANDA for Hydrocodone Bitartrate & Actaminophen  
01/10/2002 2002P-0009 National Juice Products Assn./Amend 21 CFR 120.24 concentrated and shelf-stable juice  
01/10/2002 2002V-0008 Alpha Music Inc./Laser light show  
01/11/2002 2002P-0013 Colin G. Meyer, DVM, PhD/Rescind GRAS Status for Aluminum-containing Food Additives Denied 12/09/2004
01/11/2002 2002V-0015 Hawthorn Lanes, Inc./Laser Light Show  
01/11/2002 2002V-0016 Chase Chad, Inc./Laser Light Show  
01/11/2002 2002V-0017 Silhouette Lights & Staging/Laser light show  
01/14/2002 2002V-0018 Twilight Lighting Systems/Laser Light Show  
01/15/2002 2002P-0025 National Vaccine Information Center/Immediate suspension all vaccine containing Thimerosal Denied 08/11/2005
01/16/2002 2002P-0026 Baker Norton Pharmaceuticals, Inc./ANDA for Paclitaxel, ANDA 75-184  
01/17/2002 2002P-0029 Berlex Laboratories, Inc. & 3M Pharmaceu/Mylan estradiol transdermal system as generic substitute Denied 10/22/2004
01/18/2002 2002P-0033 Lachman Consultant Services, Inc./Carbidopa & Levodopa Orally Disintegrating Tablets  
01/24/2002 2002V-0040 Defiant & Film Effects, Inc./Laser Light Show  
01/24/2002 2002V-0041 Laser Wizardry East/Laser Light Show Approved 06/08/2005; Termination date 04/09/2007
01/25/2002 2002P-0043 Michael Lisjak/Determine Pipracil Was Withdrawn For Safety Reasons  
01/25/2002 2002P-0045 Cook Biotech Incorporated/SURGISIS Periodontal Membrane (D.C. #K010952)  
01/25/2002 2002V-0044 Andy Pratt Professional Disc Jockey/Laser Light Show  
01/28/2002 2002V-0048 Musique Express/Laser Light Show  
01/30/2002 2002V-0050 Aqua Max Laser Display Inc./Laser Light Show  
01/31/2002 2002P-0056 Shotwell & Carr, Inc., Atley Pharma/(ANDA) Suitability for butalbital and acetaminophen  
Top      
February      
02/01/2002 2002P-0057 Nephron Pharmaceuticals Corp./Relisting of Ventolin Albuterol Sulfate Inhalation  
02/06/2002 2002P-0059 Hoffmann-La Roche Inc./Refrain from Approving ANDA for Isotretinoin Drug Products  
02/08/2002 2002P-0061 SterilMed, Inc./Modify the 2/14/02 deadline for Class II Reprocessed Devices  
02/08/2002 2002P-0061 Vanguard Medical Concepts, Inc./Modify the 2/14/02 deadline for Class II Reprocessed Devices  
02/11/2002 2002P-0061 Alliance Medical Corp./Modify the 2/14/02 deadline for Class II Reprocessed Devices  
02/12/2002 2002P-0067 PCRM/All estrogen-containing products intended for oral use APPROVED 10/16/2003;Terminates 09/20/2006
02/12/2002 2002P-0068 ChymoCorp/Determination of Chymopapain (Chymodiactin)  
02/12/2002 2002V-0069 AREA 54 DJ, Co./A projector for a laser light show  
02/12/2002 1975N-0183H Ciba Specialty Chemicals Corporation/Health-Care Antiseptic Drug Products for OTC Human Use  
02/15/2002 2002P-0075 GlaxoSmithKline Consumer Healthcare, LP/Flavored Candy-like Products Containing Tobacco DENIED 08/29/2003 Denied August 29, 2003
02/15/2002 2002V-0072 Hotel Devlmt-Taxas bda Illusions Cabaret/Laser Light Show  
02/19/2002 2002V-0074 J Professional Inc, DBA Radio Interactiv/Laser Light Show ANSWER 08/18/2003 Closed 08/18/2003
02/20/2002 1975N-0183H Alcavis International/Health-Care Antiseptic Drug Products for OTC Human Use  
02/21/2002 2002P-0078 Kleinfeld, Kaplan & Becker/ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20  
02/22/2002 2002V-0079 Ultrasonic DJ Services, Inc./Laser Light Show  
02/26/2002 2002P-0084 Pharmaceutical Solutions, Inc./ANADA for a generic version of trimethoprim & sulfadiazine c  
Top      
March      
03/05/2002 2002P-0089 St. Jude Medical/Allow Electronic Labeling to Meet 201(m) of FD&C Act APPROVED 09/29/2003
03/05/2002 2002V-0087 Gulf Coast Entertainment/Laser Light Show  
03/05/2002 2002V-0088 Entertainment Laser Systems/Laser Light Show  
03/05/2002 2002V-0090 Powerhouse Productions/Laser Light Show  
03/05/2002 2002V-0091 Roscoe Entertaniment/Laser Light Show  
03/05/2002 2002V-0092 Poseidon, Inc. dba Mythos/Laser Light Show  
03/05/2002 1998N-0583 Sandler, Travis & Rosenbeg, P.A./Exports: Notification and Recordkeeping requirements  
03/06/2002 2002V-0093 4th Dimension Laser, LLC/Laser light show  
03/08/2002 1998N-0583 Consumer Healthcare Products Association/Exports: Notification and Recordkeeping requirements  
03/13/2002 1998N-0583 CTFA/Exports: Notification and Recordkeeping requirements  
03/14/2002 2002P-0105 Lachman Consultant Services, Inc./ANDA Suitability for Oxycodone and Acetaminophen Tablets  
03/14/2002 2002V-0106 Cathedral of the Cross/Laser Light Show  
03/14/2002 2002V-0107 Associated Laser Productions Internal/Laser Light Show  
03/14/2002 2002V-0108 FX Lasers, Inc./Laser light show  
03/15/2002 2002V-0110 Music Gladiators Mobile Entertainment/Laser Light Show  
03/18/2002 2002V-0111 Mixed Entertainment Corporation/Laser Light Show  
03/20/2002 2002P-0116 Peiser & Associates, Inc./Sec. 480.200 Expiration Dating of Unit Dose Repackaged Drugs Approved 10/28/2005
03/21/2002 2002V-0117 Intense Lasers Inc./Laser Light Show  
03/22/2002 2002P-0120 Public Citzen Health Research Group/Request the immediate ban of Meridia (sibutramine) Denied 08/09/2005
03/22/2002 2002P-0122 CSPI/Request Rulemaking on Functional Foods & Establish Adv. Com.  
03/22/2002 2002V-0119 George W. Long, Inc./SeaBreeze Amusement/Laser light show Approved 07/13/2006
03/26/2002 2002P-0127 PharmaForce, Inc./Determine if Phenergan has been withdrawn or withheld from s  
03/26/2002 2002V-0126 Dynamic Sound Lighting & Music/Laser Light Show  
03/26/2002 2002V-0129 Area Nightclub, Inc., dba DV8/Laser Light Show  
03/27/2002 2002V-0130 Astro Audio Video & Lighting, Inc./Laser light show  
03/27/2002 2002V-0132 Sound Dimensions/Laser Light Show Approved 03/25/2005
03/28/2002 2002P-0135 Jerome Stevens Pharmaceuticals, Inc./Orally-Administered Levothyroxine Sodium all NDAs & ANDAs  
03/28/2002 2002V-0136 Farmland Entertainment, Inc./laser light show  
03/29/2002 2002P-0138 Lachman Consultant Services, Inc./ANDA for Carisoprodol Orally Disintegrating Tablets, 350mg  
Top      
April      
04/02/2002 2002P-0139 Public Citizen/Arava (leflunomide;Aventis) remove from the market Denied 03/23/2004
04/02/2002 2002P-0141 Women First Healthcare/ANDA for 1.2 mg estropipate (1.2 mg sodium estrone sulfate)  
04/04/2002 2002V-0143 Pacific Laser Production/Laser Light Show  
04/09/2002 2002V-0146 Electro Magic/Laser Light Show  
04/09/2002 1999D-0392 United Fishing Agency, Ltd./Seafood HACCP transition guidance  
04/10/2002 2002V-0153 Hitachi High-Technologies Corp. (Japan)/Laser DNA Sequencer device 3100 genetic analyzer variance.
 
04/11/2002 2002P-0148 Lavender Consulting Services, Inc/ANDA for Fenofibrate Tablets (Tricor)  
04/12/2002 2002P-0168 Arthur Blank/Request better product labeling of sports & energy beverages  
04/12/2002 2002V-0151 Cambridge Lasers Laboratories/Laser light show  
04/15/2002 2002P-0154 Biogen, Inc./The Labeling of Serono's REBIF is Misleading Withdrawn 03/02/2007
04/15/2002 2002V-0154 Western Starlight, Inc./Laser light show.  
04/15/2002 1976N-0052N Bayer Corporation/OTC Nasal Decongestants  
04/15/2002 1978N-0064 Cosmetic, Toiletry, and Fragrance Assn./OTC Antiperspirant Denied 10/7/2004
04/16/2002 2002P-0166 Auishalom Klammer/Print clear, legible & intelligible product expiration date Denied 12/15/2006
04/16/2002 2002V-0157 The Ultimate Place 2B/laser light show  
04/16/2002 2002V-0158 Sorcar Engineering, Inc./Laser Light Show Approved 05/17/2004
04/17/2002 2002P-0161 Lachman Consultant Services, Inc./ANDA Suitability for Isotretinoin Capsules 30 mg  
04/17/2002 2002P-0163 WellPoint Health Networks/Expedite Over-the-Counter Approval for Desloratidine  
04/17/2002 2002V-0162 Metropolitan Opera Association/Laser light show  
04/18/2002 2002V-0165 Eyelusions/Laser Light Show  
04/19/2002 2002P-0177 Arla Foods Ingredients amba/Health Claim: D-tagatose and Noncariogenicity  
04/22/2002 2002P-0170 Amarin Pharmaceuticals, Inc./ANDAs relaying Permax as reference listed drug not be appove  
04/22/2002 2002P-0176 Strasser & YDE,S.C./Pesticide chemical residue Pentochloronitrobenzene (PCNB)  
04/22/2002 2002V-0175 Joey's Nightclub/Laser Light Show  
04/24/2002 2002V-0186 SRO Club/Laser Light Show  
04/25/2002 2002V-0182 Vision/MCS (Memphis Concert Sound)/Laser light show  
04/25/2002 2002V-0183 Funzalosound/Laser Light Show Approved 07/13/2006
04/26/2002 2002V-0185 Creative Teen Concepts, Inc Club 17/Laser Light Show  
04/30/2002 2002P-0187 Hako-Med/Exemption of any connector in lead having a conductive conne  
04/30/2002 2002P-0189 Phoenix Scientific, Inc./Physical form of drug product in to a oral liquid generic  
04/30/2002 2002P-0191 Teva Pharmaceuticals USA, Inc./Request for immediate final approval of tramadol Hydrochlori  
04/30/2002 2002V-0188 Shore Lanes, Inc./Laser Light Show  
04/30/2002 2002V-0190 Isorad Ltd./X-Ray Fluoroscopic Inspection Systems - SDS 400/S & P  
04/30/2002 2002V-0192 Riverband Community Church/Laser Light Show  
04/30/2002 2002V-0193 Quark Lighting Technology/Laser Light Show  
04/30/2002 2002V-0194 Rauch Planetarium/Laser Light Show  
Top      
May      
05/01/2002 2002V-0195 Tinseltown/Laser light show  
05/01/2002 2002V-0196 Pure - Torbati Enterprises/Laser Light Show  
05/03/2002 2002P-0198 Richdel, Inc./ANADA for ivermectin having a different dosage form (oral ge  
05/03/2002 2002V-0197 TKO Sound/Laser Light Show  
05/06/2002 2002P-0205 Society Research on Nicotine and Tobacco/SRNT petition to regulate Ariva tobacco lozenges  
05/06/2002 2002P-0206 Society Research Nicotine and Tobacco/SRNT to regulate Omni and Adance cigarettes  
05/06/2002 2002V-0201 AV-Pro Inc./Laser Light Show  
05/06/2002 2002V-0202 Digital Jamz/Laser Light Show and Projector  
05/06/2002 2002P-0207 Society Research Nicotine and Tobacco/SRNT petition to regulate SF Garrett's Nicotine Water  
05/07/2002 2002V-0210 Michell Sales/laser light show  
05/08/2002 2002P-0211 American Environmental Safety Institute/Amend 21CFR163,"Cacao Products: Stds of Identity" Denied 4/18/2006
05/08/2002 2002P-0212 American Environmental Safety Institute/Lead & Cadmium Levels Permitted in Cocoa/Applicable Standard
 
05/08/2002 2002V-0213 PegLeg Entertainment/Laser Light Show  
05/08/2002 2002V-0214 Andrus Laser Research/Laser Light Show  
05/09/2002 2002P-0219 Altana Inc./Amend the "Orange Book" for Fluocinide Emulsified Base Approved 8/20/2003
05/13/2002 2002V-0221 Choctaw Resort Development Enterprise/Laser Light Show  
05/13/2002 2002V-0222 Laser Energy/Projector for Q-Bean Series  
05/14/2002 2002V-0223 Us and Them/Laser Light Show  
05/14/2002 2002V-0224 Q-Peak, Inc./Laser Light Show  
05/15/2002 2002P-0225 Lachman Consultant Services, Inc./ANDA for Levorphanol Tartrate Tablets  
05/15/2002 1975N-0183H Lonza, Inc./Health-Care Antiseptic Drug Products for OTC Human Use  
05/17/2002 2002P-0226 Kirkpatrick & Lockhart LLP/ANDA for methotrexate sodium oral solution, 5mg/ml Approved 10/06/2003
05/17/2002 2002V-0227 CHT Systems/Laser light show  
05/20/2002 2002V-0229 East Providence Lanes/Laser light show  
05/20/2002 2002V-0230 Montgomery County Memorial Hall/Laser Light Show, Laser Fantasy International-Rainbow I Proj  
05/21/2002 2002P-0233 Kleinfeld, Kaplan and Backer/Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA  
05/21/2002 2002V-0234 Texas Steak House dba Celebrations/Laser light show  
05/22/2002 2002V-0238 Long Island Laser Works/Laser Light Show  
05/22/2002 2002V-0239 Spellbound Productions/Laser Light Show  
05/22/2002 2002V-0240 Lazerus Laser Systems/Laser Light Show APPROVED 03/22/2005
05/28/2002 2002P-0243 Julian M. Whitaker, M.D./Require Issuance of Medication Guide for All Statin Drugs Denied 03/04/2005
05/28/2002 2002P-0244 Dr. Julian M. Whitaker, M.D./Warning Statement for All HMG Co-A Reductase Inhibitors Denied 03/04/2005
05/29/2002 2002P-0245 Gensia Sicor Pharmaceuticals, Inc./ANDA for Fludarabine Phosphate Injection, 25 mg/ML  
05/30/2002 2002P-0247 AAC Consulting Group/ANDA Suitability for Clozapine 50 mg Tablets  
05/30/2002 2002P-0249 AAC Consulting Group/ANDA for 7.5 mg Mirtazapine Tablets  
05/30/2002 2002V-0248 Princeton Alliance Church/Laser Light Show  
05/31/2002 2002P-0252 Caraco Pharms Labs, Ltd./Seek immediate final approval of generic tramadol hydrochlor  
Top      
June      
06/03/2002 2002P-0256 Mylan Pharmaceuticals, Inc./Determine if ANDA 76-122 is Entitled to 180 Days Exclusivity  
06/03/2002 2002P-0294 Orthopedic Surgical Manufacturers Assn/Polymethylmethacrylate (PMMA) Bone Cement  
06/04/2002 2002P-0246 University of Colorado Hospital/Pharmacies of hospitals/other health care entities  
06/05/2002 2002V-0262 Creative Lighting and Sound/Laser Light Show  
06/06/2002 2002V-0261 Acme Corp Production Services/Laser Light Show  
06/06/2002 2002V-0265 Canobie Lake Park/Laser Light Show Approved 06/08/2005; Termination date 03/12/2008
06/07/2002 2002V-0263 Disneyland Resort/Laser Light Show  
06/11/2002 2002V-0269 Telexport, Inc. (TEI)/Laser light show  
06/11/2002 1978N-0036L American Herbal Products Assn. & etc./OTC Laxative DENIED 07/03/2003
06/12/2002 2002P-0267 Nocona General Hospital/Amend Mammography Quality Standards Act & FOIA Approved and Denied in Part 10/21/2003
06/13/2002 2002P-0270 SciRegs/Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5  
06/17/2002 2002V-0279 Daamini/Laser light show  
06/17/2002 1998N-0583 Grocery Manufacturers of America & CTFA/Exports: Notification and Recordkeeping requirements  
06/20/2002 2002V-0287 Integrated Production Systems, Inc./Laser light show  
06/21/2002 2002P-0292 California Walnut Commission/Health Claims: Walnuts & Cornary Disease Answer 03/09/2004
06/21/2002 2002V-0283 International Laser and Light, Inc./Laser Light Show  
06/21/2002 2002V-0293 Tuco Innovations, Inc./Erchonia Low-Level Laser Device  
06/24/2002 2002P-0285 King & Spalding/Combination oxycodone hydrochloride/acetaminophen tablet  
06/24/2002 2002V-0300 Valentino/Laser light show  
06/25/2002 2002V-0286 Adams Audio Labs. Laser Div./Laser light show  
06/27/2002 2001P-0495 Ortho-McNeil/Determine Ultram's safety or effectiveness reasons  
06/27/2002 2002P-0191 Ortho-McNeil/Request for immediate final approval of tramadol Hydrochlori  
06/27/2002 2002P-0252 Ortho-McNeil/Seek immediate final approval of generic tramadol hydrochlor  
06/28/2002 2002P-0297 Lachman Consultant Services, Inc./ANDA for Propoxyphene Hydrochloride, Acetaminophen&Caffeine  
Top      
July      
07/01/2002 2002V-0301 Counter Clockwise Productions Inc./Laser Light Show  
07/02/2002 2002V-0304 Valentino/Laser Light Show  
07/10/2002 2002P-0312 CollaGenex Pharmaceuticals, Inc./Periostat (doxycycline hyclate) 20 mg Capsules Answered 05/16/2005
07/10/2002 2002P-0312 CollaGenex Pharmaceuticals, Inc./Periostat (doxycycline hyclate) 20 mg Capsules Answered 05/16/2005
07/16/2002 2002P-0317 Mission Possible International/Recall Aspartame as a Neurotoxic Drug  
07/16/2002 2002V-0318 Laser Image/Laser Light Show  
07/19/2002 2002P-0321 Miami Crab Corporation/Grant relief unwarranted testing for chloramphenicol crabmea DENIED 07/29/2003
07/22/2002 2002V-0323 The Hamlet on Olde Oyster Bay/Laser Light Show  
07/24/2002 2001E-0363 Corcept Therapeutics Inc./Patent Term Extension Application, MIFEPREX No. 4,386,085  
07/25/2002 2002V-0328 East Coast Entertainment, Inc./Laser light show  
07/26/2002 2002V-0331 Vinyl Circus/laser light show  
07/26/2002 1978N-0038 CTFA & CHPA/Sunscreen Drug Products DENIED 06/03/2003 Denied 06/03/2003
07/29/2002 2002V-0334 Solavanti, L.L.C. DBA Contour/Laser Light Show  
07/31/2002 2002P-0338 Russel J. Thomsen, MD/OTC sales, distribution all brands of hand-held doppler fet

Denied 06/19/2003

 

Top      
August      
08/01/2002 2002P-0346 Gensia Sicor Pharmaceuticals/ANDA Amiodarone Hydrochloride Injection 450mg/9ml single use  
08/02/2002 2002V-0347 Technological Artisans, Inc./Laser light show  
08/05/2002 2002P-0349 Clasen Immunotherapies, Inc./Amend product insert and/or label for Hemophilus Vaccines DENIED 06/26/2003
08/06/2002 2002V-0351 Tour & Concert Associates/Laser Light Show  
08/08/2002 2002P-0357 Bayer Corporation/Stay Effective Date of Compliance for Monograph Title Change APPROVED 06/03/2003
08/08/2002 2002V-0356 50 Liberty Pole Way, Inc. dba Gotham Cit/Laser light show  
08/09/2002 2002P-0358 The Weinberg Group Inc./ANDA for amoxicillin tabs for oral suspension 300 & 600mg  
08/12/2002 2002P-0360 J. B. Proveedores S.A. DE C./Chemical Cleaning Products for Industrial Food  
08/13/2002 2002P-0363 Merck Research Laboratories/NDA 20-560: Fosamax (Alendronate Sodium Tablets)  
08/13/2002 2002V-0364 Laser Devices, Inc./Variance Application for Infrared Laser Aiming Devices  
08/13/2002 2002V-0365 Resonant Productions, Inc./Laser Light Show  
08/13/2002 2002V-0366 The Sound Council/Laser light show  
08/15/2002 2002P-0367 West-Ward Pharmaceutical Corp./Doxycycline hyclate capsules 20mg,Periostat capsules,20mg Answered 05/16/2005
08/15/2002 2002V-0373 Beaming Man/Laser Light Show  
08/15/2002 2002V-0375 Nimar, Inc./Redline lasers beambox/Redline lasers beamscan XYR-1000  
08/15/2002 1978N-0036L Banner Pharmacaps, Inc./OTC Laxative Denied 11/17/2003
08/16/2002 2002V-0432 IVP Integrated Vision Products AB/Variance for Laser Triangulation Measurement System  
08/19/2002 2002P-0374 Boston University School of Medicine/Angiotensin Converting Enzyme inhibitors a Black Box warning  
08/19/2002 2002P-0378 Plantetary Health, Inc./Genetically Engineered Rice, Wheat, and other Essential Food  
08/20/2002 2002P-0377 Am Assn of Pro Life Obstetrician & Gyn/Petition Requesting Stay of Approval of Mifeprex  
08/20/2002 2002V-0376 Jewish DJ Service, Inc./Laser light show  
08/21/2002 2002A-0379 SG&A Consulting, Inc./Device classification resulting manufacturer for image techn  
08/22/2002 2002P-0380 Banner Pharmacaps/Abbreviated New Drug Application (ANDA) for Loperamide Hydro Interim Response 02/03/2004
08/22/2002 2002P-0424 Banner Pharmacaps Inc./ANDA for Loperamide Hydrochloride 1 mg Soft Gelatin Capsules  
08/23/2002 2002V-0382 Laser Devices, Inc./Infrared Laser Aiming Devices  
08/26/2002 2002P-0386 Pharmaceutical Associates, Inc/Abbreviated new drug application (ANDA)7.5 mg hydrocodone  
08/27/2002 2002V-0387 Sacramento Theatrical Lighting/Laser Light Show  
08/30/2002 2002P-0390 number not used/Number not used  
Top      
September      
09/03/2002 2002P-0391 IVAX Pharmaceuticals Inc./Determine Whether Alphagan has been Voluntarily Withdrawn Answer 06/19/2003
09/03/2002 2002P-0392 Barr Laboratories, Inc./Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily  
09/03/2002 2002P-0395 Barr Laboratories, Inc./Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have  
09/04/2002 2002P-0394 Taro Research Institute Ltd./Make determination of ANDA suitability for Amiodarone Hydroc  
09/04/2002 1978N-0036L Arnall Golden Gregory LLP/OTC Laxative DENIED 09/02/2003
09/05/2002 2001E-0365 Dr. Reddy's Laboratories, Ltd./Patent Term Extension Application, NEXIUM 4,738,974 Withdrawn 01/09/2007
09/05/2002 2002P-0396 Intervet Inc./Suitability Petition for Ivermectin Soft-Chew Anthelmintic  
09/05/2002 2002P-0399 Barr Laboratories, Inc./Determine Whether Estrostep 21 Tablets, NDA 020130 Have Been Closed 05/23/2007
09/05/2002 2002P-0400 Barr Laboratories/Determine Whether Niaspan Tablets, NDA 020381 Have Been  
09/05/2002 2002P-0401 Paddock Laboratories, Inc./Ammonium Lactate 12% lotion and cream for relevant  
09/05/2002 2002V-0397 Light and Sound Consultants/Laser Light Show  
09/05/2002 2002V-0398 Otherland Group, dba Xenoline.com/Laser Light Show  
09/06/2002 2002P-0404 Alcon Research, Ltd./Determination re: Withdraw of ALPHAGAN Answer 06/19/2003
09/10/2002 2002P-0406 The Weinberg Group Inc./ANDA Suitability for Amoxicillin & Clavulanate Potassium Denied 10/15/2004
09/11/2002 2002V-0408 Classic Computers, Inc./Laser Light Show  
09/12/2002 2002V-0410 Richards Audio Visual/Variance for Q-Beam Series  
09/12/2002 2002V-0411 Live Bait/Laser light show  
09/13/2002 2002P-0413 Kyl Smith, D.C./Health Claim: Phosphatidylserine and cognitive dysfunction  
09/16/2002 2002P-0414 The Weinberg Group Inc./Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA Interim Response 02/03/2004
09/17/2002 2002V-0415 Norwood Abbey Limited/LAD-01 Medical Laser Product  
09/18/2002 2002P-0416 Highland VetPharma, LLC/ANADA dosage form which differs for Ivermectin Equalan Paste  
09/23/2002 2002V-0420 Lasergrace Inc./Laser light show Approved 06/08/2005; Termination date 02/28/2008
09/24/2002 2002P-0419 Bioniche Pharma Group Limited/Amiodarone Hydrochloride Injection 50mg/mL  
09/24/2002 2002P-0422 Frommer Lawrence & Haug, LLP/Propoxyphene Napsylate and Acetaminophen 100mg/35mg and 100m  
09/26/2002 2002P-0423 Highland VetPharma, LLC/ANADA for ivermectin/pyrantel different dosage form (molded,  
09/27/2002 2002V-0425 MGM Grand Hotel/Laser Light Show ANSWER 10/31/2003
09/30/2002 2002P-0426 Andrx Pharmaceuitcals, Inc./Andrx in its currently pending ANDA 76-159 Glipizide product Withdrawn 02/06/2007
09/30/2002 2002P-0429 Highland VetPharma, LLC./Abbreviated new animal drug applicationIvermectin for cats  
Top      
October      
10/01/2002 2002P-0431 Arent Fox Attorneys At Law/Delcobese Tablets and Capsules Answered 11/13/03
10/02/2002 2002P-0435 Aventis Behring, LLC/Effective Approval of Alphanate Antihemophilic Factor  
10/02/2002 2002V-0433 Radio Interactive/Laser light show  
10/03/2002 2002P-0435 Aventis Behring, LLC/Effective Approval of Alphanate Antihemophilic Factor Withdrawn 04/27/2006
10/03/2002 2002P-0436 BioPartners GmbH/ANDA for ribavirin, USP in a water soluble film-coated table  
10/07/2002 2002P-0462 Carbolite Foods, Inc./Use of Implied Nutrient Content Claim - "Carbolite"  
10/08/2002 2002P-0437 Richard A. Stolworthy/Protect patients & consumers in U.S. by amending the 510(k)  
10/08/2002 2002P-0438 Jarrow Formulas, Inc./Warning on Labeling of Kava Dietary Supplements  
10/09/2002 2002P-0440 CSPI/Establish a Microbial Testing Program for Hazards in Seafood  
10/10/2002 2002V-0442 Abracadbra Lights & Sounds/Laser Light Show  
10/11/2002 2002P-0444 The Weinberg Group Inc./cefpodoxime Proxetil talbets for Oral suspension 50mg/100mg Interim Response 02/03/2004
10/15/2002 2001M-0210 The TMJ Association/P000035;TMJ Fossa-Eminence Prosthesis  
10/15/2002 2002P-0446 Mechanical Servants, Inc./Establish guidance re: "inner package" Convenience size drug INTERIM RESPONSE 05/15/2003 Int: 5/15/03
10/15/2002 2002P-0447 Pfizer Inc./Immediately revoke its acceptance for NDA 21-435 for amlodin Denied 10/14/2003
10/15/2002 2002P-0448 SensorMedics Corporation/ANDA Sutability for Albuterol Base Inhalation Solution Denied 12/17/2003
10/16/2002 2002P-0450 B. Braun Medical Inc./Withhold Approval of ANDA for Amino Acid Solution Drug Prod. DENIED 06/19/2003 Denied 6/19/2003
10/17/2002 2001V-0110 OmniSistem Lights Effects/Laser Light Show Approved 4/17/2006
10/17/2002 2002V-0453 Optical Magic/Laser Light Show  
10/17/2002 2002V-0455 OmniSistem Lights and Effects/Laser Light Show  
10/18/2002 2002P-0457 Wellness Lifestyles, Inc./Selenium and Anticarcinogenic effects in certain cancers2002P-0457  
10/21/2002 2002P-0459 Lachman Consultant Services Inc./Abbreviated new drug application(ANDA) for Metoprolol tartrt  
10/21/2002 2002P-0460 Caraco Pharmaceutical Labs., Ltd./25 mg metoprolol tartrate tablets drug product of ANDA  
10/21/2002 2002V-0458 Columbia DJ Supply/Laser Light Show  
10/22/2002 2002P-0464 PCH Integrated Regulatory Services, Inc./ DES 1.0 mg & 5.0 mg INTERIM RESPONSE 06/11/2003 Int: 6/11/03;LET1
10/22/2002 2002P-0465 Lachman Consultant Services, Inc./ANDA Suitability for Oxycodone & Acetaminophen Tablets  
10/25/2002 2002P-0470 Karen A. Sisson/Change Dosgae Form of Eqvalan Paste 1.87% From Paste to Gran  
10/25/2002 2002P-0494 Sirona Dental Systems, GmbH/CEREC Ceramic Dental Restoration Systems  
10/28/2002 2002P-0469 Allergan, Inc./ANDA for Brimonidine Tartrate Ophthalmic Solution 0.2% DENIED 05/21/2003 Denied 5/21/03
10/30/2002 2002P-0472 Dr. Frank I. Marcus/Petition to Post Statement in Response to Warning Letter Approved and Denied in part 10/21/2003
10/31/2002 2002P-0473 Banner Pharmacaps/ANDA for Naproxen Sodium, 220mg (equivalent to 200 mg Naprox  
10/31/2002 2002P-0474 Phoenix Scientific, Inc./ANADA for tiamulin soluble powder tiamulin hydrogen fumarate  
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November      
11/04/2002 2002V-0477 Omicron Laserage Laserprodukte GmbH/Laser Light Show  
11/05/2002 2002P-0478 Lachman Consultant Services, Inc./Fentanyl transdermal system 12.5 mcg/hr is suitable for ANDA  
11/06/2002 2002P-0479 CorePharma, LLC/Cyproheptadine Hydrochloride Tablets;Assign a (RLD) status INTERIM RESPONSE 05/28/2003 Int: 5/28/03
APPROVED 05/28/2003 Approved 68FR 31720 05/28/2003
11/07/2002 2002P-0480 Bioniche Pharma Group Limited/Amiodarone Hydrochloride Injection , 50mg/mL,9mL vial  
11/08/2002 1988N-0258 Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987; Guideline  
11/08/2002 1992N-0297 Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987, Drug Amds of 1992  
11/12/2002 2002V-0482 Sonic Wave/Laser Light Show  
11/12/2002 2002P-0481 Lachman Consultant Services, Inc/Methadone Hydrochloride Tablets, USP, 15mg, 20mg and 30(ANDA  
11/13/2002 2002P-0483 Kirkpatrick & Lockhart, LLP et al/Actions re: exceptive drug products, ex release guaifenesin  
11/14/2002 2002P-0484 Lachman Consultant Services, Inc./ANDA for Amiodarone Hydrochloride Injection 50 mg/mL  
11/14/2002 2002V-0485 Twilight Lighting Systems/Laser Light Show  
11/15/2002 2002V-0488 N/A Private Residence/Laser Light Show  
11/18/2002 2002P-0489 James H. Schafer, D.V.M./Request Revision of CVM's Bioequivalence Guidelines Approved 11/10/03
INTERIM RESPONSE 05/15/2003
Denied 12/31/2003
11/18/2002 2002P-0490 Number not used See 02P-0469 C1/Alphagan 0.2% was withdrawn from sale for reasons other  
11/21/2002 2002P-0493 Andrx Pharmaceuticals Corp./Anti-heart burn drug Omeprazole magnesium (brand Prilosec1) Denied 01/21/2005
11/22/2002 2002V-0495 Classic Computes Inc./Laser Light Show  
  2002P-0498 Taro Pharmaceuticals/ANDA Warfarin Sodium Tablets, USP 0.5 mg. (Coumadin tablets)  
11/26/2002 2002V-0497 Penguin Promotions/Laser light show  
11/27/2002 2002P-0499 The Weinberg Group Inc./ANDA Suitability for Metformin Hydrochloride Tablets Oral So APPROVED 05/14/2003
Closed 5/14/03
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December      
12/03/2002 2002V-0502 Cell Robotics, Inc./Variance Request for the Ultra-Light Laser System  
12/04/2002 2002P-0503 Roxane Laboratories/ANDA abbreviated new drug application for Digoxin Elixir  
12/04/2002 2002V-0504 Swinomish Northern Lights Casino/Laser Light Show  
12/05/2002 2002P-0505 International Tree Nut Council Nutrition/Labeling nuts & eligible nut containing products reduce risk  
12/06/2002 2002P-0506 Lachman Consultant Services, Inc./Was Wydase (Hyaluronidase) Inj. withdrawn for Safety Reasons  
12/06/2002 2002V-0507 Bear Productions/Laser Light Show  
12/06/2002 2002V-0508 Kentwig Lanes Bowling Center/Variance for Q-Beam Series, Projectors  
12/11/2002 2002V-0512 Space Based Lasers/Laser Light Show  
12/13/2002 2002V-0513 Xtremo Sound/Laser light show  
12/16/2002 2002V-0517 Psyteknology/Laser Light Show Approved 05/04/2006
12/17/2002 2002P-0520 Bicon, Inc./Reclassification of Beta-Tricalcium Phosphate,  
12/17/2002 2002V-0523 Louisiana Arts and Science Museum/Laser Light Show  
12/17/2002 2002V-0524 Central Texas College/Laser Light Show  
12/17/2002 1980N-0042 Tom's of Maineer Consumer Healthcare/Anticaries Drug Products for OTC Human Use  
12/18/2002 2002V-0522 Black Bear Jamboree/Laser Light Show  
12/18/2002 2002V-0521 White Star/Laser Light Show  
12/23/2002 2002V-0533 Laser Envy/Laser Light Show and Projector  
12/24/2002 2002V-0530 Chat Radio Inc./Club Matrix/Laser Light Show Projector  
12/27/2002 2002V-0531 Showtrends, Inc./Laser Light Show  
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