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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| 01/25/2002 | 2002P-0043 | Michael Lisjak/Determine Pipracil Was Withdrawn For Safety Reasons | ||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
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| 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 | ||
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| 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 |
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| 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 |
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| 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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