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U.S. Department of Health and Human Services

Regulatory Information

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2004 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
01/02/2004 2004P-0126 Veridex, LLC/Classification of CellSerach Epithelial Cell Kit/Cell Spotter Analyzer Approved 01/21/2004
01/07/2004 2004P-0003 Billy G. Pierson/Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
Denied 04/06/2004
12/31/2003 2004P-0004 Environmental Working Group/Correct of FDA's advice for women who are pregnant, or might become pregnant, and nursing mother, about avoiding harm to your baby or young child from mercury in fish and shellfish Pending 12/31/2003
01/07/2004 2004V-0005 King Lasers/Laser Light Show Approved 02/04/2004; Terminates 02/04/2006
01/07/2004 2004P-0006 Kleinfeld, Kaplan and Becker, LLP/abbreviated new drug applications ( ANDA's) for controlled-release oxycodone hydrochloride products that list OxyContin ( oxycodone HCI controlled-release )
Answer 03/23/2004
01/07/2004 2004V-0007 East Kentucky Science Center/Laser Light Show Approved 02/04/2004; Terminated 02/04/2006
12/30/2003 2004P-0008 Cancer Action NY/Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofura Pending 01/07/2004
01/08/2004 2004P-0009 Antonio Zamora/to clarify the use of the terms "100% Natural" and "Fat Free" in food product packages Denied 12/12/2005
01/09/2004 2004P-0013 Consumer/Review safety of Nutropin Depot Injection, issue direction to Genentech Inc. to add warnings regarding diabetes in their safety literature, and consider amending 21 CFR 314.80(e) Postmarketing studies Approved 06/01/2006
01/09/2004 2004P-0015 Buc & Beardsley/Deny approval of any New Drug Application (NDA) for recombinant salmon calcitonin (rsCT) nasal spray Denied 08/12/2005
01/13/2004 2004V-0020 Stealth DJ's Mobile Disc Jockey Services/Laser Display Device Pending 01/13/2004
01/14/2004 2004P-0037 Etymotic Research, Inc./513(f) Reclassification Petition for TV-TIP Sound Amplifier Denied 07/20/2004
01/20/2004 2004V-0029 Club LA Vela/ Laser Light Show Approved 03/10/2004
01/20/2004 2004V-0030 HB Stereo Inc./Projector for a Laser Light Show Approved 02/17/2004; Terminates 02/17/2006
01/20/2004 2004P-0032 Pennfield Oil Company/ANADA for the Pioneer Products NADA 35-805 Aureo S 700 Type a medicated article (Chlortetracycline, Sulfamethazine) Approved 03/24/2004
01/21/2004 2004P-0036 State of Louisiana Department of Health and Hospitals/Office of Mental Health be deemed pharmacies of other health care entities language of 503(d)(3)(A0(ii), and be allowed to inventory and dispense drug samples to patients Approved 05/17/2004
01/28/2004 2004P-0043 State of Connecticut/Require Purdue Pharma to revise labeling of OxyContin Tablets Interim Response 07/21/2004
02/02/2004 2004P-0048 Abbott Laboratories/Abbreviated new drug application (NDA) suitability for Ondanaetron Hydrochloride Withdrawn 03/22/2004
02/05/2004 2004V-0052 Clark Planetarium/Laser Light Show Pending 02/05/2004
02/05/2004 2004V-0053 Minolta Planetarium-De Anza C College/Laser Light Show Approved 06/18/2004; Approved 06/08/2005; Terminates 06/18/2007
02/05/2004 2004P-0054 Mutual Pharmaceutical Company, Inc./Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules, 75mg and 100 MG NDA 50-582 Withdrawn 03/29/2004
02/06/2004 2004P-0056 Lachman Consultant Services, Inc. ANDA for Ondansetron Orally Disintegrating Tablets Approved 07/07/2004
02/09/2004 2004V-0057 Entertainment USA of Tn DBA Platinum Plus/Laser Light Show Pending 02/09/2004
02/09/2004 2004P-0051 Arent Fox, Kintner Plotkin & Kahn PLLC/Dyclone (dyclonine hydrochloride) Topical Solution 0.5% and 1.0% (NDA 9-925) was voluntarily withdrawn or withheld from sale for reasons other then safety or efficacy Answered 11/17/2004
02/09/2004 2004P-0058 Bimeda A Division of Cross Group/Market Phenylbutazone powder that is the same formulation as the approved NADA Butatron (phenylbutazone) tablets Withdrawn 02/25/2004
02/10/2004 2004P-0061 Jerome Stevens Pharmaceuticals, Inc./Establish guidance and clarify requirements for abbreviated new drug applications for levothyroxine sodium products Denied 06/23/2004
02/11/2004 2004P-0055 Bio-Rad Laboratories/Issue a written opinion stating that Bio-Rad's longstanding practice, previously accepted by the agency, of developing unified, truthful labeling for domestic and international sales Denied 05/02/2007
02/13/2004 2004P-0070 Watson Pharma, Inc./Withhold approval of any abbreviated New Drug Application (ANDA) for a generic version of Ferrlecit (sodium ferric gluconate complex in sucrose) until conditions of petition are met Interim Response 08/05/2004
02/13/2004 2004P-0068 Ferring Pharmaceuticals, Inc./Establish specific bioequivalence requirements for oral products containing desmopressin Interim Response 07/30/2004; Denied 07/01/2005
02/13/2004 2004P-0069 Lachman Consultant Service, Inc./Declare that Fentanyl Transdermal Systems, in strengths of 37.5 mcg/hr, 62.5 mcg/hr, and 87. mcg/hr are suitable for submission in an ANDA Approved 07/07/2004
02/13/2004 2004P-0060 Rotta Pharmaceuticals Inc./Health Claim Petition: Glucosamine Sulfate and Osteoarthritis Denied 10/07/2004
02/13/2004 2004P-0059 Weider Nutrition International Inc/Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis Denied 10/07/2004
02/17/2004 2004P-0067 Robert Cohen/Revoke the regulation that approved Posilac, Monsanto's bovine growth hormone Interim Response 06/03/2004
02/18/2004 2004P-0074 Savient Pharmaceuticals, Inc. / Oxandrolone and widely used anti-coagulant drugs containing the active drug warfarin Denied 12/01/2006
02/18/2004 2004P-0075 Mylan Pharmaceuticals Inc/Prohibit the marketing and distribution of Authorized Generics until the expiration of the fir generic applicant's exclusivity period Denied 07/02/2004
02/24/2004 2004P-0085 Bedford Laboratories/Esmoloi Hydrochloride for injection 2,500 mg/vital in a lyophilized form is suitable for evaluation under an ANDA Denied 02/24/2004
02/25/2004 2004P-0088 Barbara E Kennedy-Neslusan/petition to modify requirements for prescription/non prescription drug labeling Interim Response 08/20/2004
02/26/2004 2004P-0091 Gastroparcsis & Dysmotilities Assn./Premarket approval (PMA) for the gastric electrical stimulation (GES), level IIII device, enterra therapy, for the treatment of severe nausea and vomiting from gastroparesis Denied 11/04/2004
02/27/2004 2004P-0092 RRD International, LLC/ANDA Suitability Petition for Potassium Iodid Oral Solution 65 mg per mL Approved 03/03/2004
03/01/2004 2004V-0094 Inflatable Promotions and Searchlights/Laser Light Show Approved 03/11/2004
03/01/2004 2004V-0095 Club Lotus/Laser Light Show Approved 04/02/2004
03/03/2004 2004V-0096 Young Harris College/Laser Light Show Approved 03/25/2004; Terminated 03/25/2006
03/03/2004 2004V-0108 Fastshotters/Projector for a Laser Light Show Pending
03/03/2004 2004V-0104 Pamalor Inc./Laser Light Show Approved 04/02/2004
03/03/2004 2004V-0109 Full House Productions/Laser Light Show Pending
03/04/2004 2004V-0106 HTE/Laser Light Show Approved 03/25/2004; Terminates 03/24/2006
03/04/2004 2004V-0112 Intelligent Dance Factory/Laser Light Show Approved 04/12/2004
03/05/2004 2004P-0113 Public Citizen/Immediate removal of rosuvastatin Denied 03/11/2005
03/09/2004 2004V-0119 John Coodey CLLS/Laser Light Show Approved 08/16/2004
03/09/2004 2004V-0120 Laser Energy/Laser Light Show Approved 04/12/2004
03/09/2004 2004V-0121 Ringtail Studios/Laser Light Show Pending
03/09/2004 2004P-0122 University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School/Remove Category X Categorization for Estradiol in Use-in-Pregnancy Labeling Interim Response 08/30/2004
03/10/2004 2004P-0123 Lachman Consultant Services, Inc./Glimepiride Tablets, 3mg and 6 mg for an Abbreviated new Drug Application Approved 07/07/2004
03/11/2004 2004P-0105 Kraft Foods North American Inc/Nutrient Content Claim: Total Carbohydrate Content of Foods Pending
03/11/2004 2004P-0107 ConAgra Foods/Nutrient Content Claim: Carbohydrate Content of Foods Pending
03/11/2004 2004P-0110 Grocery Manufacturers of American (GMA)/Nutrient Content Claim: Carbohydrate Content of Foods Pending
03/12/2004 1992V-0286 Dreamspell/Variance Request for Mobolazer ML-10A Light Show Closed See 2004V-0211
03/12/2004 2004V-0211 Dreamspell/Variance for Moralizer ML 10 300 Approved 06/18/2004
03/12/2004 2004P-0125 Lachman Consultant Services, Inc./Sertraline hydrocholide tablets, 150 mg and 200 mg are suitable for submission in an ANDA Withdrawn 04/02/2004
03/12/2004 1995N-0304 Chinese Herbal Products Committee of the American Herbal Products Association/Ephedrine Alkaloids: Reports of Adverse Events Pending
03/16/2004 2004P-0127 Smart Drug Systems, Inc./ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs and cats (NADA 120-161) Denied 05/12/2004
03/16/2004 2004P-0128 Smart Drug Systems, Inc./ANADA for clavamox (amoxicillin trihydrate/clavulanate potassium) tablets for dogs and cats Denied 05/13/2004
03/16/2004 2004P-0129 American Longeviry, Inc./Modify Current Regulation Governing Structure/Function Claims, 21CFR Pt. 101.93 Interim Response 10/07/2004
03/16/2004 2004P-0130 Smart Drug Systems, Inc./ANADA for AMOXI-TABS (amoxicillin) for dogs and cats Withdrawn 05/21/2004
03/17/2004 2004P-0131 SourceCF, Inc./ANDA Suitability for Tofin (Tobramycin for Inhalation) Pending
03/18/2004 2004P-0136 Intevet, Inc./ANADA Suitability Petition for Florfenicol Injectable Solution Approved 05/19/2004
03/19/2004 2004V-0135 NEC/IBES Local Union #159 LMCC Trust/Laser Light Show Approved 04/27/2004
03/19/2004 2004V-0137 Intelligent Dance Factory/Laser Light Show Pending
03/19/2004 2004V-0138 The Beat of Time/Laser Light Show Approved 04/19/2004
03/19/2004 2004P-0139 McNeil Consumer & Specialty Pharmaceuticals/Approval of Generic Version of Concerta (methylphenidate HCl extended-release tablets are both bioequivalent and clinically equivlent to the innovator product) Interim Response 09/07/2004
03/19/2004 2004P-0140 King Pharmaceuticals, Inc./Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling Interim Response 09/07/2004
03/23/2004 2004P-0141 Abbott Laboratories/NDA 19-443 Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons Answer 11/30/2004
03/25/2004 1995V-0043 NexRay/ Variance for the Scanning Beam Digital X-Ray System Pending
03/26/2004 2004P-0148 The Weinberg Group Inc./ANDA Suitability for Oxycodone Hydrochloride 5 mg, 10 mg and 20 mg tablets Approved 09/28/2004
03/26/2004 2004P-0149 Endo Pharmaceuticals, Inc./ANDA Suitability for 2.5 mg oxycodone hydrochloride/325 acetaminophen and 5 mg oxycodone hydrochloride/325 mg acetaminophen Withdrawn 04/26/2006
03/26/2004 2004P-0150 Endo Pharmaceuticals, Inc./ANDA Suitability for 7.5 mg oxycodone hydrochloride/325 mg acetaminophen and 10.0 mg oxycodone hydrochloride/325 mg acetaminophen Withdrawn 04/26/2006
03/30/2004 2004P-0152 The Weinberg Group Inc./ANDA Suitability for Hydromorphone Hydrochloride Tablets 2 mg and 4 mg dosage strengths Approved 09/28/2004
03/30/2004 2004P-0153 The Weinberg Group Inc./ANDA Suitability for Oxycodone Hydrochloride Capsules for Oral administration, 5 mg, 10 mg, 20 mg, and 30 mg. Denied 05/17/2005
03/31/2004 2004V-0155 Valley Forge Composite Technologies/Valley Forge Composite Technologies Explosive Detection Systems Withdrawn 04/24/2006
04/01/2004 2004P-0003 Consumer/Petition to reconsider the Food and Drug Administration's decision on the Med Watch Complaint Pending
04/01/2004 2004P-0157 The Weinberg Group Inc/ANDA Suitability for Amoxicillin and Clavulanate Potassium Tablets for Oral Suspension 200 mg/28.5 mg and 400 mg /57 mg Approved 09/28/2006
04/05/2004 2004P-0162 Lachman Consultant Services, Inc./Zoloft (sertaline hydrochloride) Tablets 150 mg and 200 mg Answered 09/22/2004
04/06/2004 2004P-0140 Mutual Pharmaceutical Co., Inc./Rescind the March 1, 2004 Dear Applicant Letter Regarding Metaxalone Labeling Pending
04/06/2004 2004P-0164 Philips Medical Systems/Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators Withdrawn 10/29/2004
04/08/2004 2004P-0167 First Priority, Inc./ANADA for a generic equivalent of the innovator products, Garacin (gentamicine sulfate) Pig Pump Oral Solution Withdrawn 04/22/2004
04/08/2004 2004P-0168 Lachman Consultant Services, Inc./ANDA Suitability for Glipsizide and Metformin Hydrochloride Oral Solution Approved 11/23/2004
04/08/2004 2004P-0169 Coalition to Preserve DSHEA/Erroneous Interpretation of the Statutory Definition of the Term "Dietary Supplement" Interim Response 10/07/2004
04/08/2004 2004P-0171 Genentech, Inc./Standard of "Similarity" or "Sameness" of Biotechnology-Derived Products Answer 05/30/2006
04/12/2004 2004V-0172 Saturn Communications/Projector for a Laser Light Show Pending
04/12/2004 2004P-0173 Lachman Consultant Services, Inc./ANDA for Cefprozil Tablets for Oral Suspension, 125 mg and 250 mg Denied 06/07/2005
04/13/2004 1978N-0036L Purdue Frederick Company/OTC Laxative Approved 01/07/2005
04/14/2004 2004P-0177 State of Illinois/Provide Certification to Congress Under Section 804(l) of Chapter VII of the Federal Food, Drug, and Cosmetics Act, and to Authorize a Pilot Program for Importation of Prescription Drugs in Illinois Pending
04/14/2004 2004P-0175 Intervet Inc./ANADA for a generic intravaginal progesterone insert for cattle that differs from the pioneer product (EAZI-BREED CIDR) Approved 07/28/2004
04/21/2004 2004P-0183 Nestle Prepared Foods Company (Nestle)/ Nutrient Content Claim: Expand Lean Definition Closed 01/12/2007 NFR 1 72FR1455 1/12/07
04/22/2004 2004V-0190 Stealth DJ's Mobile Disc Jockey Service/ Laser Light Show Pending
04/22/2004 2004V-0191 New Jersey State Museum Planetarium/ Laser Light Show Approved 05/25/2004
04/26/2004 2004P-0197 First Priority, Inc/ANADA for Pig Pump Oral Solution, NADA 130-464 Approved 06/24/2004
04/26/2004 2004P-0196 Fommer Lawrence & Haug LLP/ ANDA for ribavirin, USP tablets in Strengths of 400 mg and600 mg Approved 09/28/2004
04/27/2004 2004P-0195 Lachman Consultant Services, Inc./ANDA for Divalproex Sodium Extended-Release Tablets, 750 mg Approved 09/28/2004
04/28/2004 2004P-0202 National Family Farm Coalition/ Notify State & Federal regulators of GRAS requirements of milk protein concentrate Pending
05/03/2004 2004P-0206 Bell, Boyd & Lloyd LLC/No abbreviated new drug application for Fluticasone Propionate Nasal Spray will be approved, unless it contains bioavailability and bioequivalence studies Denied 02/22/2006
05/04/2004 2004P-0208 The Weinberg Group, Inc /ANDA for Glipizide and Metformin HCl Tablets for Oral Suspension Approved 11/23/2004
05/04/2004 2004P-0209 The Weinberg Group/ ANDA Suitability for Glyburide and Metformin HCl Tablets for Oral Suspension Approved 11/23/2004
05/06/2004 2004P-0213 Lachman Consultant Services, Inc/ Determine that Pravastatin Sodium Tablets 60 mg is suitable for consideration in an abbreviated new drug application (ANDA) Approved 09/28/2004
05/06/2004 2004P-0216 Lachman Consultant Services, Inc/ ANDA Suitability for Pravastatins Sodium Tablets 30 mg Approved 09/28/2004
05/06/2004 2004P-0219 Lachman Consultant Services, Inc/ ANDA Suitability for Doxycycline Monohydrate Capsules, 150 mg Pending
05/07/2004 2004V-0218 Dreamlight Laser Productions/ Laser Light Show Approved 6/09/2004
05/07/2004 2004P-0220 Wapner, Newman, Wigrizer, Brecher/Determine that the reference listed drug Zithromax (azithromycin) oral capsules, NDAs 50-670 was not withdrawn from sale for reasons related to safety or effectiveness Interim Response 10/27/2004
05/07/2004 2004V-0224 Tobco Inc dba The Waterwaters Pub/ Projector for a Laser Light Show Pending
05/07/2004 2002P-0225 Celltech Americas, Inc./ NDA 21-259 Metadate CD Extended-Release Capsules Interim Response 10/20/2004
05/11/2004 2004P-0222 Stradling Yocca Carlson and Rauth/ANDA for a preservative-free ciprofloxacin HCL (3.5mg/mL equivalent to 3.0 mg/ML base) ophthalmic solution in unit dose containers (04. mL) Pending
05/11/2004 2004P-0223 General Mills Inc/ Whole Grain Descriptive Claims Denied 11/08/2005
05/11/2004 2004P-0227 Wiley Rein & Fielding LLP/ Adhere to the statutory limitations of section505(j)(5)(b)(iv) of the ACT in issuing final approvals to ANDA applicants Denied 07/02/2004
05/14/2004 2004P-0003 Bill Pierson/Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint Pending
05/14/2004 2004V-0229 Thunder & Lightning Inc/ Projector for a Laser Light Show Pending
05/14/2004 2004P-0231 Pfizer Inc/Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [rDNA origin] for injection, lyophilized powder and diluent with preservative Interim Response 11/10/2004, Answer 05/30/2006
05/15/2004 2004N-0217 Alaska General Seafoods, Ocean Beauty Seafoods, Inc, Trans-Ocean Products, Inc./ Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids) Interim Response 11/27/2007
05/17/2004 2004V-0232 K/OS Promotions/ Laser Light Show Pending
05/18/2004 2004P-0235 Finkelstein and Partners/ Request addition of Postmarketing Suicide Reports to the Neurontin Labeling Interim Response 11/05/2004
05/18/2004 2004P-0236 Center for Science in the Public Interest (CSPI) / Revoke the Authority to Industry to USe Partially Hydrogenated Vegetable Oils in Foods Pending
05/19/2004 2004P-0237 FEERDIC, Incorporated/ Fundamental Fairness Requires FDA to Treat all News Medical, Including the Trade Press, Faily and Equitably Pending
05/19/2004 2004V-0238 Excalibur Night Club/ Projector for a Laser Light Show Approved 06/09/2004
05/19/2004 2004P-0239 GlaxoSmith Kline(GSK)/ Issue a Final and Complete Guidance Document to Determine Bioequivalence (CE) for Nasal Spray Products Denied 02/22/2006
05/20/2004 1978N-0036L C B Fleet Company/ OTC Laxative Approved in part and Denied in part 10/06/2004
05/20/2004 2004V-0240 Crown & Anchor / Projector for a Laser Light Show Approved 06/30/2004
05/20/2004 2004V-0241 Sergio Gonzalez / Projector for a Laser Light Show Approved 06/30/2004
05/24/2004 2004P-0243 Lachman Consultant Services, Inc/ Oxycodone and Acetaminophen tablet USP, 2.5 mg/400 mg. 5 mg/400mg, 7.5 mg/400 mg and 20 mg/400 mg Withdrawn 06/28/2004
05/25/2004 2004P-0247 Alphapharm Pty Ltd of Glebe/ Escitalopram oxalate may be filed for ANDA capsule dosage form Pending
05/26/2004 1975N-0183H HY- GENE Biomedical Corporation / Health-Care antiseptic Drug Products for OTC Human Use Pending
05/27/2004 2004P-0252 Lachman Consultant Services, Inc/ ANDA Suitability for Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/700 mg, 7.5mg/700 mg, and 10mg/700 mg Approved 10/18/2005
05/28/2004 2001P-0075 Pharmacists Planning Service, Inc/ Switch Status of Emergency Contraceptives from Tx to OTC Pending
06/01/2004 2002P-0414 The Weinberg Group Inc. / Cefuroxime Axetil Tablets Oral Suspension 125 mg & 250 mg ANDA Pending
06/04/2004 2004V-0255 Texas State Technical College / Laser Display Device Pending
06/10/2004 1975N-0183H HY-GENE Biomedical Corporation/Health-Care Antiseptic Drug Products for OTC Human Use Interim Response 12/13/2004
06/10/2004 2004P-0261 Teva Pharmaceuticals USA, Inc./ Prevent Pfizer Inc. from marketing a generic version of Accupril until after the expiration of Teva's 180-day exclusivity period Denied 07/02/2004
06/10/2004 2004P-0262 King & Spalding LLP/Withdraw approval of ANDA suitability petition Approved 02/23/2007
06/10/2004 2004P-0127 Smart Drug Systems, Inc./ ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs & cats (NADA 120-161) Denied 10/27/2004
06/14/2004 2004P-0263 Lupin Pharmaceuticals, Inc./ To declare that the drug Cefixine chewable tablets, 100 mg, 150 mg and 200 mg are suitable for an abbreviated new drug application Approved 10/06/2005
06/14/2004 2004P-0265 Winston Laboratories, Inc./Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different from zucapsaicin Denied 09/08/2005
06/17/2004 2004P-0266 Environmental Working Group/Take immediate action to cease the unlawful distribution of misbranded, adulterated and unlabeled cosmetics Denied 09/29/2005
06/21/2004 2004V-0268 Iole Allessandrini/Projector for a Laser Light Show Pending
06/25/2004 2004P-0271 D'ARCY Revolutionary Skincare/Determine that Drying Lotion, a Topical Acne Drug Products for Over the Counter Use, can contain in combination both Sulfur (10.0%0 and Salicyclic Acid (2.0%) as the active ingredient Denied 12/29/2004
06/26/2004 2004P-0315 Pharmacists Planning Service, Inc (PPSI)/ Switch Pseudoephedrine from Over the Counter (OTC) Sales Denied 01/08/2007
06/28/2004 2004V-0272 Fan Yang/Projector for a Laser Light Show Approved 07/14/2004
06/28/2004 2004V-0273 Vybe Entertainment/ Laser Light Show Approved 07/14/2004
06/28/2004 2004V-0274 Brent Freiday/Projector for a Laser Light Show Approved 07/15/2004
06/30/2004 2004V-0278 Laser Super Sales/Laser Light Show Approved 07/29/2004
07/01/2004 2004P-0276 Computerized Thermal Imaging, Inc./Initiate Proceedings to permit Computerized Thermal Imaging, Inc. (CTI) to supplement the administrative record in connection with CTI's premarket approval application in P010035 Pending
07/01/2004 2004V-0277 Linden Laser Systems/Laser Light Show Approved 11/09/2006
07/02/2004 2004P-0419 PerkinElmer Life and Analytical Sciences/ de nova classification of NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit, Model MS-8970 Approved 08/24/2004
07/06/2004 2004V-0284 Jose Ayala/Projector for a Laser Light Show Approved 07/27/2004
07/06/2004 2004P-0285 Lachman Consultant Services, Inc./To determine whether Aciphex (rabeprozole sodium) delayed-release tablets, 210mg (NDA 20-973) has been voluntarily withdrawn or withheld from sale for safety or effectiveness reasons Closed 03/28/2005
07/07/2004 2004P-0280 Nico Worldwide, LLC/ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution Denied 05/27/2005
07/07/2004 2004P-0281 Nico Worldwide, LLC/ANDA for Nicotine Base Oral Solution 2 mg base per 240 mL oral solution and 4mg base per 240 mL oral solution in bottles Pending
07/07/2004 2004P-0282 Nico Worldwide, LLC/ANDA Nicotine Bitartrate Oral Solution 2 mg base per 240 mL oral solution and 4mg base 240 mL oral solution in bottles Pending
07/08/2004 2004V-0288 Luxor Hotel & Casino/Laser Light Show Pending
07/08/2004 2004P-0290 GlaxoSmithKline Research & Development/Refrain from approving any ANDA for a topical mupirocin calcium product containing the amorphous form of the active ingredient Interim Response 12/22/2004
07/09/2004 2004V-0292 Arctic Ice Arena/Laser Light Show Approved 08/09/2004
07/09/2004 2004P-0294 McNeil Nutritionals, Div. of McNeil - PPC, Inc./ Health Claim Petition: Noncariogenicity Dental Health Claim for Sucralose Pending
07/12/2004 2004P-0293 National Starch and Chemical Company/ Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates Interim Response 12/20/2004
07/12/2004 2004P-0295 Lachman Consultant Services Inc/ To determine whether Zyvox (linezolid) tablets 400 mg (NDA 20-130) were withdrawn for safety or effectiveness reasons Answered 06/30/2005
07/13/2004 2004V-0305 Oddyssey Enterprises/Laser Light Show Approved 08/16/2004
07/15/2004 1981N-0033 Dyclo9, Inc., / Oral Health Care Drug Products for OTC Human Use Withdrawn 03/14/2005
07/15/2004 2004V-0317 Caliente Resort LLC/Laser Light Show Approved 08/16/2004
07/15/2004 2004V-0318 Sun on the Beach/Laser Light Show Approved 08/02/2004
07/15/2004 2004P-0320 Abbott Laboratories/ Refrain from approving certain applications submitted under section 505(b)(2) of the FDCA that reference Depokote (divalproex sodium delayed-release tablets) Interim Response 01/11/2005; Withdrawn 07/21/2006
07/16/2004 2004P-0297 Center for Science in the Public Interest (CSPI) / Nutrient Content Claim: Define Terms Low Carbohydrate, Reduced Carbohydrate and Carbohydrate Free Pending
07/16/2004 2004P-0298 Unilever United States Inc / Nutrient Content Claims for the Carbohydrate Content of Food Pending
07/16/2004 2004P-0299 Frito-Lay Inc./ Nutrient Content Claims for Carbohydrates Pending
07/16/2004 2004P-0321 Lachman Consultant Services, Inc./ ANDA for Benzonatate Capsules USP, 150 mg Approved 11/23/2004
07/20/2004 2004P-0324 Dey LP/ ANDA filed by Ivax Pharmaceuticals for a generic formulation of DuoNeb is subject to a 30-month stay of approval Pending
07/21/2004 2004P-0326 Apotex Corp./ANDA for Adenosine Injection, USP Denied 08/22/2007
07/22/2004 2004P-0328 Center for Science in the Public Interest (CSPI) / Restaurants indicate Food they Serve Contains Trans Fat from Partially Hydrogenated Vegetable Oils Denied 12/15/2006
07/23/2004 2004P-0387 Abbott Laboratories/ Request the FDA take action described methodology for oral levothyroxine sodium drug products Pending
07/23/2004 2004P-0126 Abbott Laboratories/ Refrain from approving ANDA for Levothyroxine Sodium Tablet Pending
07/23/2004 2004P-0334 Hyman Phelps & McNamara/ Submit Validation Data for Reprocessed Single-Use Electrosurgical Cutting and Coagulation Devices and Accessories Answer 11/03/2005
07/26/2004 2004P-0329 Russel J Thomsen MD/ Consider the Appropriate Regulatory Status for Low Ouput, Hand-Held Doppler Fetoscopes Answer 02/25/2005; Denied 07/06/2006
07/28/2004 2004V-0335 Canisius High School/ Projector for a Laser Light Show Approved 08/19/2004
07/28/2004 2004V-0336 CLLS Laser Show the Forum/ Laser Light Show Pending
07/29/2004 2004P-0339 Fommer Lawrence & Haug LLP/ Refuse to file an ANDA for the combination drug amiodipine besylate-benazepril hydrochloride (amlodipine benazepril) Approved 07/11/2006
07/30/2004 2004P-0340 VA Palo Alto Health Care System/ Action on Regulation of Generic Transdermal Fentanyl Delivery System, and new Product Approvals for Transdermal Fentanyl Products Denied 01/28/2005
08/04/2004 2004P-0348 Frommer Lawrence & Haug LLP/ ANDA for Fluticasone Proprionate Nasal Spray, 50 mcg Denied 02/22/2006
08/04/2004 2004P-0349 Coalition for Mercury-free Drugs (CoMeD/Action on Products Containing Added Mercury Denied 09/26/2006
08/04/2004 2004P-0351 STD Prevention and COntrol Service/Change the Labeling and take Further Action to address the Association of Viagra (Sildenafil) Use and Increased STD Transmission, Including HIV Infection Denied 09/29/2006
08/05/2004 2004P-0353 Lachman Consultant Service, Inc., / ANDA Suitability for Famotidine Orally Dissolving Strips 10 mg Approved 07/05/2005
08/05/2004 2004P-0354 Microgenics Corporation/CEDIA Sirolimus Assay as a class II device Approved 09/30/2004
08/06/2004 2004P-0359 Methapharm Inc./ Suitability Petition for Methacholine Chloride 1280 mg/vial Pending
08/09/2004 2004P-0357 City of Arlington, Texas/ Determine that an Advisory Opinion or Exemption is not needed in accordance with FDA regulations for Automatic External Defrillators Answer 03/15/2005
08/09/2004 2004P-0358 Guitar Center #220/ Projector for a Laser Light Show Approved 08/31/2004
08/10/2004 2004P-0360 AAC Consulting Group/ANDA for Ferrlecit Injection 5ml/62.5 mg of elemental iron Pending
08/11/0024 2004V-0362 Carl Zeiss Jena GmbH/Laser Display Device Pending
08/12/2004 2004V-0363 Shaun Hernandez/ Projector for a Laser Light Show Approved 09/01/2004
08/12/2004 2004V-0364 Prouducciones Latino/Projector for a Laser Light Show Approved 09/01/2004
08/16/2004 2004P-0365 Shire US, Inc. ANDA for Agrylin (anagrelide hydrochloride) Capsules Denied 04/18/2005
08/18/2004 2004P-0368 Northwest Community Healthcare/ Interchangeability of Medical Devices with One ANother Pending
08/18/2004 2004P-0070 Watson Pharma, Inc./ Withhold Approval of any ANDA for a generic version of Ferrlecit (sodium ferric gluconate complex in sucrose) until certain conditions are met Interim Response 02/09/2005
08/20/2004 2004P-0372 Intervet Inc. / ANADA suitability for generic carprofen chewable tablet Interim Response 10/20/2004
08/20/2004 2004P-0373 Gray Cary Ware & Freidenridch LLP / ANDA for Omeprazole Magnesium Delayed Release Capsules, Eq. to 20 mg base for OTC Approved 07/05/2005
08/20/2004 1995N-0304 American Herbal Products Association / Ephedrine Alkaloids: Reports of Adverse Events Pending
08/24/2004 2004P-0376 Bioniche Animal Health USA, Inc. / ANADA for a generic intravaginal progesterone insert for cattle that differs from the pioneered product Approved 11/03/2004
08/25/2004 2004P-0379 AAC Consulting Group/ Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons Answer 09/08/2005
08/27/2004 2004V-0380 Delta Marine / Laser Light Show Approved 05/22/2006
08/31/2004 2004P-0383 Ancare New Zealand LTD / ANADA for a different concentration of active Ivermectin Pour-On for cattle Approved 11/16/2004
08/31/2004 2004P-0384 Ancare New Zealand LTD / ANADA for different concentration, presentation ( ready to use solution ) of Levamisole Hydrochloride for cattle and sheep Approved 11/16/2004
08/31/2004 2004P-0386 Abbott Laboratories & Laboratories Fournier / Rejection New Drug Application 21-695 Denied 11/30/2004
09/01/2004 2004P-0390 Lachman Consultant Services Inc. / ANDA Suitability for Doxycycline Hyclate Tablets, 75 mg and 100 mg

Withdrawn 06/14/2005


09/03/2004 2004V-0400 Travis Hopkins / Laser Light Show Pending
09/03/2004 2004P-0365 Shire US, Inc / Refrain from approving ANDA for Agrylin (anagrelide hydrochloride) Capsules Denied 04/18/2005
09/07/2004 2004P-0406 Hikma Farmaceutica (Portugal), Lda / ANDA for Betamethasone Sodium Phosphate Answer 01/12/2006
09/08/2004 2004P-0405 Lachman Consultant Services, Inc. / ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg per 5 mL Denied 07/28/2005
09/08/2004 2004P-0407 Hikma Farmaceutica (Portugal), Lda/ Was Bethamethasone Sodium Phosphate withdrawn for safety reasons Answer 01/12/2006
09/08/2004 2004P-0409 Lachman Consultant Service, Inc., / ANDA Metoclopramide Hydrochloride Orally Disintegrating Tablets 5 mg & 10 mg Withdrawn 10/11/2005
09/08/2004 2004P-0411 Eva Kasparova / Compel Enforcement and Regulation of Amyl Nitrate Denied 01/10/2006
09/13/2004 2004P-0418 Lachman Consultant Services, Inc./ Atorvastatin Calcium Capsules, 10 mg, 20 mg, 40 mg, and 80 mg for an abbreviated new drug application Withdrawn 06/02/2005
09/14/2004 2004P-0417 F H Faulding & Co. Limited t/a Mayne Pharma Int'l / ANDA Doryx (coated doxycycline hyclate pellets) in powder or other fill present Withdrawn 06/14/2006
09/17/2004 2004V-0424 Poet Productions, LLC / Laser Light Show Approved 10/08/2004
09/17/2004 2004P-0429 Industry Coalition / Revoke 212 CFR Part 11 in its entirety, and pursue implementation of electronic record and signature Interim Response 03/15/2005
09/22/2004 2004P-0434 Ben Venue Laboratories, Inc./ ANDA for additional dosage of Fluconazole Injection, 100 mg / 50 mL Approved 08/18/2006
09/22/2004 2004V-0435 David Ceremuga / Variance for 250 mg, 532nm DPSS Laser with an IR Filter



09/29/2004 2004V-0447 We Will Rock You Vega/ Rock You Vegas LLC / Laser Light Show Pending
10/01/2004 2004P-0448 Dermaceuticals, Inc./ DERMA-SMOORHE/FE (fluocinolone acetonide 0.01% topical Oil) Interim Response 03/24/2005
10/04/2004 2004V-0449 Pacific Science Center/ Laser Light Show

Approved 05/19/2005; Termination date: 05/19/2007


10/05/2004 2004P-0451 NuTec Incorporated/ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets Interim Response 03/24/2006
10/06/2004 2004P-0452 Bunny Abraham/Regulate the use of coding on food labels Denied 11/21/2005
10/12/2004 2004P-0457 Endotec, Incorporated/Reclassification of the Buechel-Pappas Unconstrained ANkle Prosthesis Withdrawn 11/02/2004; Answer 06/20/2005
10/20/2004 2004P-0464 The Beverage Institute of Health & Wellness LLC/ Vitamin D and Calcium and Reduced Risk of Osteoporosis Interim Response 10/20/2004
10/26/2004 2004P-0473 Carbolite Foods, Inc./ Labeling Claims Using Net Effective Carbohydrates and Similar Terms Pending
10/26/2004 2004P-0472 Dr. Daniel Brookoff and Dr. Eric A. Voth/ Refuse Final Approval to ANDA 76-258 for a Generic Fentanyl Transdermal System Under Its Current Proposed Labeling Denied 01/28/2005
10/26/2004 2004V-0475 C C Slaughters/ Laser Light Show Pending
10/26/2004 2004P-0483 Center for Science in the Public Interest / Rulemaking on Nutrition Labeling for Food and Beverages Sold in Single-Serving Containers Pending
11/02/2004 2004P-0485 Kirkpatrick and Lockhart LLP/ Require the source of the Dietary Ingredient Lycopene be Identified as from Tomato, Fungus or Synthetic Pending
11/02/2004 2004P-0490 Prostrong, Inc./ Labeling of Anti-Fungal Drug Products Denied 03/30/2005
11/05/2004 2004P-0488 GlaxoSmithKline/Refrain from receiving, reviewing, and approving any ANDA for a nasal mupirocin calcium product that contains the amophous form of the active pharmaceutical ingredient Pending
11/05/2004 2004P-0489 Bionich Animal Health, USA, Inc./ ANADA Suitability Petition for generic serum gonadotropin and chorionic gonadotropin for injection Withdrawn 11/09/2004
11/05/2004 2004P-0507 Bioniche Animal Health USA, Inc. / ANADA for generic Hyaluronate sodium injectable solution Withdrawn 11/09/2004
11/08/2004 2004V-0492 It's A Party Entertainment/Laser Light Show Pending
11/10/2004 2004P-0500 Lachman Consultant Services, Inc./ Meperidine Hydrochloride Tablets in two strengths of 75 mg and 105 mg suitable for ANDA Approved 03/31/2005
11/12/2004 2004P-0504 Lachman Consultant Services, Inc. / ANDA for DiaBeta (glyburide) Tablets, 5 mg Approved 04/18/2005
11/15/2004 2004V-0505 XEFX Productions/ Laser Light Show Pending
11/16/2004 2004P-0506 Alza Corporation/ Fentanyl transdermal products reduce the potential for abuse of certain types of these products Denied 01/28/2005
11/16/2004 2004V-0508 Jake Barner Studios / Projector for a Laser Light Show Approved 11/06/2004
11/16/2004 2004P-0511 ACIC Fine Chemicals, Inc. / ANDA for Methadholine Chloride 1280 mg/vial Pending
11/17/2004 2004P-0513 Beth Rosenshein / Amend regulations to update 'Estrogens Increase the Risk of Endometrial Cancer' prescribing information of all strengths of Premarin tablets Denied 01/30/2006
11/17/2004 2004P-0514 Lachman Consultant Services Inc. / Selegiline Hydrochloride Orally Disintegrating Tablets, 5 mg for an ANDA Pending
11/18/2004 2004P-0512 National Barley Foods Council/Health Claim Petition for Soluble Fiber From Barley Withdrawn 12/29/2003
11/18/2004 2004P-0512 National Barley Foods Council/Health Claim Petition for Soluble Fiber From Barley Pending
11/19/2004 2004P-0517 CollaGenex Pharmaceuticals, Inc. / Stay approval of any ANDAs for which CollaGenex's Periostat (doxycycline hyclate 20 mg) is the primary NDA Denied 05/13/2005
11/19/2004 2004P-0518 Ben Venue Laboratories / ANDA for Terbutaline Sulfate Injection Pending
11/22/2004 2004P-0520 IVAX Pharmaceuticals, Inc. /180-Day Exclusivity for Ipratropium Bromide and Albuterol Sulfate Withdrawn 09/15/2006
11/22/2004 2004V-0521 Hot Wax Unlimited / Laser Light Show Approved 12/06/2004
11/23/2004 2004P-0522 The Tatia Oden French Memorial Foundation/ Off Label Drug Use for CYTOTEC Interim Response 05/23/2005
11/24/2004 2004P-0523 GlaxoSmithKline/Generic Fluticasone Propionate Nasal Spray Products meet the same High Standards of Quality as GSK's Brand-Name Product Flonase Closed 02/22/2006
11/29/2004 2004P-0522 Grateful Doula Services / Off Label Drug Use for CYTOTEC Interim Response 05/23/2005
11/30/2004 2004P-0528 Cardinal Health/ANDA suitability for preoperative prep containing a chlorhexidine gluconate (CHG)/isopropol alcohol (IPA) solution with tint Withdrawn 11/17/2006
12/01/2004 2004P-0532 Amit Wohl / Sample distribution by mail or common carrier Interim Response 05/26/2005
12/03/2004 2004V-0536 Forum Developers Limited Partnership / Laser Light Show Pending
12/06/2004 2004V-0537 Tribal Existance Productions / Projector for a Laser Light Show Approved 10/31/2005
12/06/2004 1994P-0036 International Dairy Foods Association / Req. labeling of trans fatty acid & Prohibit deceptive claims Pending
12/07/2004 2004P-0540 Long and Mead / Don't approve any new or pending ANDA for generic fentanyl transdermal product Denied 01/28/2005
12/09/2004 2004P-0542 MGP Ingredients, Inc. / Nutrient Content Claims to Carbohydrates in Food Labeling Pending
12/10/2004 2004P-0544 Olsson, Frank and Weeda, PC / ANDA for ondansetron hydrochloride injection, 8mg / 4 mL prefilled syringes Pending
12/15/2004 2004V-0547 Tinsletown 17 / Laser Light Show Pending
12/15/2004 2004V-0548 Mezzanotte LLC / Pr0ojector for a Laser Light Show Pending
12/15/2004 2004P-0550 Arent Fox / Determine that Astra Zeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn or withheld from sale for reasons other than safety or efficacy Interim Response 06/14/2005
12/21/2004 2004P-0551 AKZO Nobel/ ANADA Suitability petition for Omeprazole Tablet for Horses Approved 01/28/2005
12/21/2004 2004V-0552 G & G Sound and Lighting / Laser Light Show regarding Mobolazer RG-50 Beam Pending
12/21/2004 2004V-0553 Varian Medical Systems / Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems Pending
12/22/2004 2004P-0557 Valeant Pharmaceuticals International / ANDA for a generic version of Efudex Cream (fluorouracil) Interim Response 06/14/2005
12/27/2004 2004P-0560 Lachman Consultant Services, Inc. / ANDA Suitability for Acetaminophen, Butalbital, Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg Approved 03/31/2005
12/27/2004 2004P-0561 Lachman Consultant Services, Inc., / ANDA Suitazbility for Acetaminophen, Butalbital and Caffeine Capsules USP, 30 mg/50mg/40 mg PendingApproved 03/31/2005
12/27/2004 2004P-0562 Methapharm Inc./Request immedicate recall of all unapproved methacholine chlorie products Interim Response 06/22/2005; Denied 09/04/2007
12/27/2004 2004P-0563 Andrx Pharamceuticals, Inc./Re-evaluate FDA's policy concerning the marketing of "Authorizied generic" versions of brand name prescription drugs Interim Response 06/24/2005
12/27/2004 2002N-0434 The American Association of Homeopathic Pharmacists, Inc./ Withdrawal of certail Proposed Rules & Other Proposed Action Pending
12/27/2004 1979P-0265 The American Associatin of Homeopathic Pharmacists, Inc. / Exemp Homoepathic Drug Productions from GMP Regulations Pending