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 |
|---|---|---|---|
| January | |||
| 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 |
| Top | |||
| 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; 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 |
| Top | |||
| 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 | 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 |
| Top | |||
| 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 | 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 |
| Top | |||
| May | |||
| 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 |
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| 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 | 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 |
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| 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 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 |
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| August | |||
| 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 |
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| September | |||
| 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 |
Pending
|
| 09/29/2004 | 2004V-0447 | We Will Rock You Vega/ Rock You Vegas LLC / Laser Light Show | Pending |
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| October | |||
| 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 |
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| November | |||
| 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 |
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| December | |||
| 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 |
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