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Chronological List of Petitions and Advisory Opinions

From January 1, 2004 through October 22, 2004

See recent additions * New/Updated Items

To view actual documents, make a note of the docket number. Click on http://www.fda.gov/search.html, enter the docket number. You will then get everything associated with that docket number.

"65FR78494" indicates a notice of some type was published in the Federal Register (FR) for a particular date. The FR can be found at http://www.fda.gov/ohrms/dockets/ and then go to the Federal Register section.

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Interim response is not necessarily any type of decision. It may state only that the agency has not yet reviewed their petition.

Approved or denied depends on what the petitioner requested. It is important to read the response letter and petition to get the correct decision.

We are unable to post/link all documents at this time but are working towards that goal.

CHRONOLOGICAL LIST OF PETITIONS AND ADVISORY OPINIONS
February | March | April | May | June | July | August | September | October
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 pregnent, 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 Interim Response 08/11/2004
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 Interim Response 07/02/2004
01/09/2004 2004P-0015   Buc & Beardsley/Deny approval of any New Drug Application (NDA) for recombinant salmon calcitonin (rsCT) nasal spray Interim Response 07/02/2004
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
February        
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
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 Interim Response 07/29/2004
02/09/2004 2004P-0058   Bimeda A Divisio of Cross Group/Market Phenylbutazone powder that is the same formlation 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 Interim Response 07/08/2004
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
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 Interim Response 08/10/2004
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 Pending 02/24/2004
02/25/2004 2004P-0088   Barbara E Kennedy-Neslusan/petition to modify requirements for prescription/non prescription drug labeling Interim Resonse 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 Pending 02/26/2004
02/27/2004 2004P-0092   RRD International, LLC/ANDA Suitability Petition for Potassium Iodid Oral Solution 65 mg per mL Approved 03/03/2004
March        
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 Interim Response 09/01/2004
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 Mobilazer ML-10A Light Show Closed See 2004V-0211
03/12/2004 2004V-0211   Dreamspell/Variance for Mobalazer ML 10 300 Approved 06/18/2004
03/12/2004 2004P-0125   Lachman Consultnat 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 suitablity 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 Pending
03/19/2004 2004P-0139   McNeil Consumer & Specialty Pharmaceuticals/Approval of Generica 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 Interim Response 09/14/2004
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 Pending
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 Pending
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. Pending
03/31/2004 2004V-0155   Valley Forge Composite Technologies/Valley Forge Composite Technologies Explosive Detection Systems Pending
April        
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 Pending
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 Pharmaceutial 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 Interim Response 07/23/2004
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   Lach Consulant Services, Inc./ANDA Suitability for Glipsizide and Metformin Hydrochloride Oral Solution Pending
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 Pending
04/12/2004 2004V-0172   Saturn Communications/Projecctor 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 Pending
04/13/2004 1978N-0036L   Purdue Frederick Company/OTC Laxative Pending
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 Progrram 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) Pending
04/21/2004 2004P-0183   Nestle Prepared Foods Company (Nestle)/ Nutrient Content Claim: Expand Lean Definition Pending
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
May        
05/03/2004 2004P-0206   Bell, Boyd & Lloyd LLC/No abbreviated new drug applicatino for Fluticasone Propionate Nasel Spray will be approved, unless it contains bioavailability and bioequivalence studies Pending
05/04/2004 2004P-0208   The Weinberg Group, Inc /ANDA for Glipizide and Metformin HCl Tablets for Oral Suspension Pending
05/04/2004 2004P-0209   The Weinberg Group/ ANDA Suitability for Glyburide and Metformin HCl Tablets for Oral Suspension Pending
05/06/2004 2004P-0213   Lachman Consultant Services, Inc/ Determine that Pravastatin Sodium Tablets 60 mg is suitable for considation 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 Pending
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 Pending
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/Petittion 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 Pending
05/15/2004 2004P-0217   Alaska General Seafoods, Ocean Beaauty Seafoods, Inc, Trans-Ocean Products, Inc./ Nutrient content claims: DHA, EPA, and ALA (Omega-3 Fatty Acids) Pending
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 Pending
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 Pending
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 Pewnding
05/26/2004 1975N-0183H   HY- GENE Biomedical Corporation / Health-Care aAntiseptic 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 Pending
05/28/2004 2001P-0075   Pharmacists Planning Service, Inc/ Switch Status of Emergency Contraceptives from Tx to OTC Pending
June        
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 Pending
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 Pending
06/10/2004 2004P-0127   Smart Drug Systems, Inc./ ANADA suitability for ANTIROBE (clindamycin hydrochloride) capsules for dogs & cats (NADA 120-161) Pending
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 Pending
06/14/2004 2004P-0265   Winston Laboratories, Inc./Designate an official name for cis-8-methyl-N-vanillyl-6-nonenamide different from zucapsaicin Pending
06/17/2004 2004P-0266   Environmental Working Group/Take immediate action to cease the unlawful distribution of misbranded, adulterated and unnlabeled cosmetics Pending
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 Pending
06/26/2004 2004P-0315   Pharmacists Planning Service, Inc (PPSI)/ Switch Pseudoephedrine from Over the Counter (OTC) Sales Pending
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
July        
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 08/09/2004
07/06/2004 2004V-0284   Jose Ayala/Projector for a Laser Light Show Approved 07/27/2004
07/06/2004 2004P-0285   Lachman Consultnat 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 Pending
07/07/2004 2004P-0280   Nico Worldwide, LLC/ANDA for Nicotine Polacrilex, 2 mg base per 240 mL oral solution Pending
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 Pending
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 Startch and Chemical Company/ Carbohydrate Labeling - Remove Dietary Fiber from Total Carbohydrates Pending
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 Pending
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 Pending
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) Pending
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 Pending
07/20/2004 2004P-0324   Dey LP/ ANDA filed by Ivax Pharmaceuticals for a generic formulatino of DuoNeb is subject to a 30-month stay of approval Pending
07/21/2004 2004P-0326   Apotex Corp./ANDA for Adenosine Injection, USP Pending
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 Pending
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 Pending
07/26/2004 2004P-0329   Russel J Thomsen MD/ Consider the Appropriate Regulatory Status for Low Oouput, Hand-Held Doppler Fetoscopes Pending
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 2004V-0339   Fommer Lawrence & Haug LLP/ Refuse to file an ANDA for the combination drug amiodipine besylate-benazepril hydrochloride (amlodipine benazepril) Pending
07/30/2004 2004P-0340   VA Palo Alto Health Care System/ Aciton on Reglation of Generic Transdermal Fentanyl Delivery System, and new Product Approvals for Transdermal Fentanyl Products Pending
August        
08/04/2004 2004P-0348   Frommer Lawrence & Haug LLP/ ANDA for Fluticasone Proprionate Nasal Spray, 50 mcg Pending
08/04/2004 2004P-0349   Coalition for Mercury-free Drugs (CoMeD/Action on Products Containing Added Mercury Pending
08/04/2004 2004P-0351   STD Prevention and COntrol Service/Change the Laveling and take Further Action to address the Association of Viagra (Sildenafil) Use and Increased STD Transmission, Including HIV Infection Pending
08/05/2004 2004P-0353   Lachman Consultant Service, Inc., / ANDA Suitability for Famotidine Orally Dissolving Strips 10 mg Pending
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 Pending
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 Inejction 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 Pending
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 Pending
*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 Pending
08/20/2004 1995N-0304   American Herbal Products Assocaition / Ephedrine Alkaloids: Reports of Adverse Events Pending
08/24/2004 2004P-0376   Bioniche Animal Health USA, Inc. / ANADA for a feneric intravaginal progesterone insert for cattle that differs from the pioneed product Pending
08/25/2004 2004P-0379   AAC Consulting Group/ Determine whether Penthrane inhalation has been voluntarily withdrawn from sale for safety or efficacy reasons Pending
08/27/2004 2004V-0380   Delta Marine / Laser Light Show Pending
08/31/2004 2004P-0383   Ancare New Zealand LTD / ANADA for a different concentration of active Ivermectin Pour-On for cattle Pending
08/31/2004 2004P-0384   Ancare New Zealand LTD / ANADA for different concentration, presentation ( ready to use solution ) of Levamisole Hydrochloirde for cattle and sheep Pending
08/31/2004 2004P-0386   Abbott Laboratories & Laboratories Fournier / Rejection New Drug Application 21-695 Pending
September        
09/01/2004 2004P-0390   Lachman Consultnat Services Inc. / ANDA Suitability for Doxycycline Hyclate Tablets, 75 mg and 100 mg

Pending
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 Pending
09/07/2004 2004P-0406   Hikma Farmaceutica (Portugal), Lda / ANDA for Betamethasone Sodium Phosphate Pending
09/08/2004 2004P-0405   Lachman Consultant Services, Inc. / ANDA Suitability for Tramadol Hydrochloride Oral Solution, 50 mg per 5 mL Pending
09/08/2004 2004P-0407   Hikma Farmaceutica (Portugal), Lda/ Was Bethamethasone Sodium Phosphate withdrawn for safety reasons Pending
09/08/2004 2004P-0409   Lachman Consultant Service, Inc., / ANDA Metoclopramide Hydrochloride Orally Disintegrating Tablets 5 mg & 10 mg Pending
09/08/2004 2004P-0411   Eva Kasparova / Compel Enforcement and Regulation of Amyl Nitrate Pending
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 Pending
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 Pending
*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 electornic record and signature Pending
09/22/2004 2004P-0434   Ben Venue Laboratoreis, Inc./ ANDA for additional dosage of Fluconazole Injection, 100 mg / 50 mL Pending
09/22/2004 2004V-0435   David Ceremuga / Variance for 250 mg, 532nm DPSS Laser with an IR Filter

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

Pending
10/05/2004 2004P-0451   NuTec Incorporated/ANDA Suitability for Carbinoxamine Maleate 4 mg Chewable Tablets Pending
10/06/2004 2004P-0452   Bunny Abraham/Reglate the use of coding on food labels Pending
10/12/2004 2004P-0457   Endotec, Incorporated/Reclassification of the Buechel-Pappas Unconstrained ANkle Prosthesis Pending
*10/20/2004 2004P-0464   The Beverage Institute of Health & Wellness LLC/ Vitamin D and Calcium and Reduced Risk of Osteoporosis Pending

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