Regulatory Information
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2003 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 | Dockets # | Name of Petitioner/Subject Matter | Disposition |
|---|---|---|---|
| January | |||
| 01/02/2003 | 2003V-0003 | R. J. Enterprises/Laser light show | |
| 01/03/2003 | 2003V-0004 | John Weber/Laser Light show | |
| 01/06/2003 | 2003P-0006 | Lachman Consultant Services, Inc./Determine if Levorphanol Tartrate withdrawn for safety reaso | Withdrawn 4/20/06 |
| 01/06/2003 | 2003V-0005 | Baton Rouge Communications/Laser Light Show | |
| 01/10/2003 | 2003V-0012 | Revision Entertainment/Laser Light Show | |
| 01/16/2003 | 2003P-0013 | First Priority, Inc./ANADA Privermectin Equine Oral Liquid for Horses | |
| 01/22/2003 | 1975N-0183H | CTFA and Soap and Detergent Association/Health-Care Antiseptic Drug Products for OTC Human Use | INTERIM RESPONSE 05/15/2003 Int: 5/15/03 |
| 01/23/2003 | 2003P-0021 | Amphastar Pharmaceuticals, Inc./Withdrawal of Wydase, Hyaluronidase Injection | INTERIM RESPONSE 07/14/2003 , Answered 11/06/2003 |
| 01/23/2003 | 2003V-0019 | Stefano Moris/Laser Light Projector | |
| 01/23/2003 | 2003V-0020 | Friction Events/Laser Light Show | |
| 01/23/2003 | 1978N-0227 | Ethex Corporation/Trimethobenzamide Hydrochloride Injection & Capsules | DENIED 12/29/2003 |
| 01/23/2003 | 1988V-0165 | Laser Image Productions, Inc./Variance re Laser light show projector (LIP-88-1) | |
| 01/28/2003 | 2001P-0290 | Hodgson Mill/Definition for the term "stone ground" for wheat flour | DENIED 12/24/2003 |
| 01/28/2003 | 2001P-0290 | Hodgson Mill/Definition for the term "stone ground" for wheat flour | DENIED 12/24/2003 |
| 01/28/2003 | 2003P-0027 | Eoc Labs, Inc./Amend labeling for skelaxin (metaxalone) tablets to restore | INTERIM RESPONSE 07/20/2003 |
| 01/28/2003 | 2003V-0026 | Long Beach Transit/Laser Light Show | |
| 01/29/2003 | 2003V-0028 | Queen Street Inc. DBA "Wibs"/Laser Light Show | |
| 01/29/2003 | 2003P-0029 | American Lung Association/Remove metered-dose inhalers (MDI) containing moiety albuter | Approved 07/15/2004 |
| 01/30/2003 | 2003P-0039 | Orphan Medical/Policy regarding users fee and Orphan Drug | Withdrawn 08/11/2006 |
| 01/31/2003 | 2003P-0041 | Bunker Hill Cheese Co., Inc./Exemption of Section 403 for application of Name Yogurt Chee | |
| 01/31/2003 | 2003V-0042 | Laserwurx, LLC/Laser Light Show Projector | Approved 06/08/2005; Termination date 03/07/2008 |
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| February | |||
| 02/04/2003 | 2003V-0047 | Lightwave Lasers/Projector Model Number 3130 for Laser Light Show | |
| 02/07/2003 | 2003V-0052 | Lance Pilon/Laser Light Show | APPROVED 09/29/2003 Approved 09/29/2003;Expires 09/29/2005 |
| 02/11/2003 | 2003V-0054 | Louis J. Roussel, Jr. Planetarium/Laser Light Show | |
| 02/11/2003 | 2003V-0055 | Steve Carlson/Laser Light Skhow | |
| 02/11/2003 | 2003V-0073 | Mr. Alex Tseng/A laser display device | |
| 02/13/2003 | 2002P-0462 | Carbolite Foods, Inc./Use of Implied Nutrient Content Claim - "Carbolite" | |
| 02/13/2003 | 2003P-0067 | Rapid Precision Testing Labs./Amend CFR to include provision to establish prescription sun | Denied 6/16/2003;PDN1 |
| 02/13/2003 | 2003V-0058 | SHOWLASERS INC/Laser Light Show | Closed 03/03/2003 Moved to 1980P-0495 |
| 02/13/2003 | 1977N-0094 | Bayer Healthcare, LLC/OTC Internal Analgesic, Antipyretic & Antirheumatic Products | INTERIM RESPONSE 08/08/2003 |
| 02/19/2003 | 2003P-0064 | Aventis Pharmaceuticals Inc./Withhold Approval of Generic Lovenox (enoxaparin sodium inje | |
| 02/25/2003 | 2003V-0071 | Rhythm of the Road/Laser Light Show | |
| 02/26/2003 | 2003V-0072 | ADJ Connection/Laser Light Show | |
| 02/26/2003 | 2003V-0074 | Synergy Laser & Image/Laser Light Show | |
| 02/27/2003 | 2003P-0078 | American Spice Trade Assn, Assn. of Food/Public Health Security & Bioterrorism Preparedness & Response | Interim Response 11/04/03 |
| 02/28/2003 | 2003V-0080 | Sierra Flo Co., LLC/Laser Light Show | APPROVED 06/23/2003 ;Terminates 6/23/2005 |
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| March | |||
| 03/04/2003 | 2003P-0082 | Lachman Consultant Services, Inc./Abbreviated New Drug Application (ANDA) for Ursodiol Oral | APPROVED 08/13/2003 |
| 03/04/2003 | 2003P-0083 | Taro Pharmaceuticals, U.S.A., Inc./ANDA suitability for carbamazepine tablets, 100mg, 300mg,400 | APPROVED 12/17/2003 |
| 03/06/2003 | 2003P-0089 | Andrx Pharmaceutical, Inc./Loratadine in 10 Milligrams Orally Disintegrating Tablets | Denied 10/9/03 |
| 03/07/2003 | 2002P-0321 | John Keeler & Co./Grant relief unwarranted testing for chloramphenicol crabmea | DENIED 07/29/2003 |
| 03/07/2003 | 2003P-0090 | Public Citizen/Removing Serzone (nefazodone) from the market Bristol-Myers | Denied 06/14/2004 |
| 03/07/2003 | 2003P-0091 | Lachman Consultant Services, Inc./ANDA to declare that drug prod Hydrocodone Polistirex & Chlo | |
| 03/12/2003 | 2002P-0285 | King & Spalding LLP/Combination oxycodone hydrochloride/acetaminophen tablet | Denied 07/30/2004 |
| 03/12/2003 | 2003V-0095 | FX Unlimited/Laser Light Show | |
| 03/12/2003 | 2003V-0096 | P A Systems & Lighting/Laser Light Show | |
| 03/13/2003 | 2003P-0097 | Jones Pharma/Unithroid as reference listed drug for levothyroxine sodium | ANSWER 10/01/2003 Petition is moot in part and denied in part 10/1/2003 |
| 03/13/2003 | 2003V-0098 | Digital Smoke and Mirrors/Laser Light Show | APPROVED 05/15/2003 Approved 5/15/03 Terminated 5/15/05 |
| 03/13/2003 | 2003V-0099 | Siemens Medical Solutions USA, Inc./Aluminum Equivalent Cantilevered Tabletop Angiography System | |
| 03/13/2003 | 2003V-0100 | Beam Bouncers Inc./Laser Light Show | Approved 05/15/2006 |
| 03/13/2003 | 2003V-0101 | Bedroxx/Laser Light Show | Approved 05/15/2006 |
| 03/14/2003 | 2003P-0105 | Mettler Electronics Corp./Revoke Medical Device Tracking Order | ANSWER 05/28/2003 Withdrawn 05/28/2003 |
| 03/17/2003 | 2003V-0103 | The Quest/Laser Light Show Red-Lin #XYP-1000/2 Controller,XYP-1000Head | |
| 03/20/2003 | 2003P-0107 | Mylan Pharmaceuticals Inc./Synthroid (levothyroxine sodium) Tablets (NDA 21-402) | |
| 03/20/2003 | 2003P-0108 | Cross Vetpharm Group, Ltd./Permit ANADA for Apramycin Sulfate Soluble Powder | Approved 6/4/2003 |
| 03/20/2003 | 2003P-0109 | American Herbal Products Assn./Promulgate regulation mandating adverse reporting for dietar | |
| 03/20/2003 | 2003P-0110 | Faulding Pharmaceutical Company/ANDA Suitability for Epirubicin Hydrochloride Injection | APPROVED 08/13/2003 Approved August 13, 2003 |
| 03/21/2003 | 2003P-0113 | Mylan Pharmaceuticals, Inc./Levoxyl (levothyroxine sodium) tablets (NDA #21-301) | |
| 03/25/2003 | 2001P-0573 | National Center for Tobacco-Free Kids/Petition for Regulation of S & F Nicotine Water | |
| 03/25/2003 | 2003P-0119 | Lachman Consultants Services, Inc./ANDA for Methadone Hydrochloride Tablets USP,15mg,20mg,30mg | |
| 03/25/2003 | 1981N-0033A | Sinofresh Research Labs, LLC/Oral Health Care Drug Product; Oral Antiseptic Drug Products | Denied 04/21/2005 |
| 03/26/2003 | 2003P-0121 | Biovail Corporation/Enforcing the patent certification requirements in FD&C Act | INTERIM RESPONSE 09/23/2003 |
| 03/27/2003 | 2003P-0123 | Orthopedic Surgical Mfrs Assn (OSMA)/Reclassification for Polymethylmethacrylate Bone Cement | |
| 03/27/2003 | 2003V-0124 | Universal Studios Florida/Laser Light Show | Approved 06/16/2005; Termination date 04/14/2008 |
| 03/28/2003 | 2003P-0126 | Jones Pharma Inc.(Jones) King Pharma./Refrain from approving (ANDA)for Levothyroxine Sodium Tablet | INTERIM RESPONSE 09/16/2003 |
| 03/28/2003 | 2003V-0125 | Insight Technology Incorporated/Infrared Laser Aiming Device | Approved 05/09/2003; Approved 12/26/2006 |
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| April | |||
| 04/01/2003 | 2003V-0127 | Entertainment Service/Laser Light Show | |
| 04/01/2003 | 2003V-0129 | Plur Entertainment LLC.d.b.a Club Fusion/Laser Light Show | |
| 04/01/2003 | 2003V-0130 | Introspective Laser Lighting ECT., LTD/Laser Light Show | Approved 06/06/2003 |
| 04/01/2003 | 2003V-0131 | Laser Design Productions/Laser Light Show | APPROVED 11/03/2003; Approved 05/19/2005; Termination date: 05/20/2005 |
| 04/02/2003 | 2003P-0132 | International Dairy Foods Association/Part 135 FDA regulations standard of identity frozen dessert | INTERIM RESPONSE 09/26/2003 Int: 09/26/2003 |
| 04/02/2003 | 2003P-0162 | J.M. Investments, Inc. D.B.A. Lucky/Import Canadian food products that do not meet labeling regs | WITHDRAWN 08/22/2003 Withdrawn 8/22/2003 |
| 04/03/2003 | 2003V-0133 | Restaurant Tatiana/Laser Light Show | Approved 05/07/2003 Approved 06/01/2006 |
| 04/07/2003 | 2003V-0138 | KDPS/Laser Light Show | APPROVED 06/26/2003 Approved June 26, 2003 |
| 04/07/2003 | 2003V-0155 | Mojo-Laser/Laser light show | APPROVED 05/12/2003 Approved 5/12/03 |
| 04/08/2003 | 2003P-0140 | GlaxoSmithKline/Refrain from Approving ANDAs for Topical Mupirocin Ointment | INTERIM RESPONSE 09/25/2003 |
| 04/14/2003 | 2003V-0156 | Epic Beat Productions/Laser Light Show Projector | |
| 04/14/2003 | 2003P-0340 | Spectral Diagnostics, Inc./Request for Evaluation of Automatic Class III Designation (De Novo) for Endotoxin Activity Assay (EAA) (K021885) | APPROVED 10/31/2003 |
| 04/16/2003 | 2003P-0159 | Lachman Consultant Services, Inc./Venlafaxine Hydrochloride Extended-Release Tablets | APPROVED 03/30/2005 |
| 04/16/2003 | 2003P-0160 | Genpharm, Inc. of Etobicoke (Canada)/FDA to send letter ruling refusing to approve loratadine tab | INTERIM RESPONSE 10/23/2003 |
| 04/18/2003 | 2003P-0166 | Associated Pharmacologists & Toxicologis/Revoke Approval for Marketing of Menstrual Cups | Answer 11/18/2003 |
| 04/23/2003 | 2003P-0171 | Del Monte Corp./Amend the standard of identity for canned tomatoes. | |
| 04/24/2003 | 2003P-0176 | Biotechnology Industry Organization/Follow-Up Approval of Therapeutic Protein Products | Answer 05/30/2006 |
| 04/25/2003 | 2003P-0178 | Lachman Consultant Services, Inc./ANDA Suitability for Divalproex Sodium Extended-Release Tabs | |
| 04/25/2003 | 2003V-0177 | Lighting & Sound Consultants/Laser Light Show | |
| 04/28/2003 | 2003V-0179 | Musititlan Entertainment/Laser Light Show | APPROVED 08/19/2003 Approved August 19, 2003 |
| 05/01/2003 | 2003P-0183 | Hawaii Pride, LLC/180 Day Tentative responses under 21CFR5.10/21CFR 10.30 | |
| 05/01/2003 | 2003P-0184 | Samson Medical Technologies, L.L.C./Permit filing of ANDA for nafcillin for injection, USP, phar | |
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| May | |||
| 05/01/2003 | 2003V-0185 | Creative Consultants, LLC/Laser Light Show | Approved 05/27/2003, Approved 03/31/2005 |
| 05/05/2003 | 2003P-0188 | The Weinberg Group Inc./ANDA Suitability for Glyburide & Metformin HCl Tablets | Approved 07/30/2004 |
| 05/07/2003 | 2003V-0192 | Fun Factory Mobile DJs/Laser Light Show | APPROVED 05/29/2003 |
| 05/08/2003 | 2003P-0196 | Pharmacists Planning Services, inc./Switch Nicotrol Inhaler (nicotine Inhalation System) From Prescription to Over the Counter Status | Denied 04/02/2004 |
| 05/13/2003 | 2003P-0107 | Abbott Laboratories/Synthroid (levothyroxine sodium) Tablets (NDA 21-402) | DENIED 11/07/2003 |
| 05/13/2003 | 2003P-0113 | Abbott Laboratories/Levoxyl (levothyroxine sodium) tablets (NDA #21-301) | DENIED 11/07/2003 |
| 05/14/2003 | 2003P-0218 | The Weinberg Group Inc./ANDA for Glipizide and Metformin HCI Tablets for Oral Solution | |
| 05/15/2003 | 2003P-0220 | Faulding Pharmaceutical Company/ANDA for Carboplatin, 10mg/mL, in strength of 600 mg/60 mL | APPROVED 10/01/2003 |
| 05/19/2003 | 2003P-0214 | Mutual Pharmaceutical Company/Correct the listing of Quinidine extended-release tablets in Orange Book |
|
| 05/19/2003 | 2003P-0219 | Vetoquinol N.-A. Inc./ANADA Suitability for Amoxicillin Oral Paste | APPROVED 07/31/2003 |
| 05/21/2003 | 2003V-0208 | Laser Entertainment SRL/Laser Light Show | |
| 05/21/2003 | 2003P-0210 | Abbott Laboratories/Withdraw decision granting petitions 03P-0107 and 03P-0113 | DENIED 11/07/2003 |
| 05/23/2003 | 2003V-0215 | US Air Force Research Laboratory/Laser Light Show | |
| 05/23/2003 | 2003P-0216 | HRA Pharma/ANDA for a drug product(1.5 mg levonorgestrel tablet) in strength(Plan B 0.75 mg Levonorgestrel tablet) in strength |
DENIED 12/17/2003 |
| 05/23/2003 | 2003P-0217 | Ranbaxy Laboratories Limited/Concept of shared exclusivity for multiple ANDA submitted on the same day | CLOSED 07/31/2003 |
| 05/23/2003 | 1975N-0183H | CTFA and SDA/Health-Care Antiseptic Drug Products for OTC Human Use | APPROVED 07/07/2003 |
| 05/23/2003 | 2003P-0223 | Richdel, Inc./ANADA Suitability for Ivermectin | APPROVED 07/31/2003 |
| 05/23/2003 | 1994P-0036 | Bantransfats.com/Req labeling of trans fatty acid & prohibit deceptive claims | |
| 05/27/2003 | 2003P-0227 | Samson Medical Technologies, LLC/ANDA Suitability Petition for Cefoxitin | APPROVED 10/01/2003 |
| 05/27/2003 | 2003V-0230 | River Palms Resort Casino/Laser Light Show | APPROVED 06/23/2003; Terminates 6/23/2005 |
| 05/28/2003 | 2003P-0301 | Assurance Medical, Inc./Classification of the Breast Lesion Documentation System | APPROVED 07/28/2003 |
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| June | |||
| 06/02/2003 | 2003P-0258 | Erick Swanson/Carotenoid astaxanthin to have the label " color added" or artificial color | |
| 06/03/2003 | 2003P-0237 | United Research Laboratories, Inc./ANDA Suitability Petition for Propranolol HCI Extended-Release Tablets, 60 mg, 80 mg, 120 mg and 160 mg |
APPROVED 10/01/2003 |
| 06/03/2003 | 2003P-0238 | The Weinberg Group Inc/ANDA Suitability Petition for Clarithromycin Extended-Release Tablets | APPROVED 12/18/2003 |
| 06/05/2003 | 2003V-0239 | GEKD, Inc./Laser Light Show | APPROVED 07/30/2003 ;Terminated 07/30/2005 |
| 06/10/2003 | 2003V-0265 | Nier of Texas, Inc. DBA South Beach/South Beach Laser Light Show and Projector Laser Spectacles Luxme 3003 | APPROVED 07/10/2003 |
| 06/11/2003 | 2003P-0266 | Olsson,Frank and Weeda,P.C./Lovenos(enoxaparin sodlium),NDA 20-164(90mg/0.6ml(product number 006),was not withdrawn from sale for reasons of safety or effectiveness sponsored by Aventis Pharmaceuticalls inc. | Answer 03/08/2004 |
| 06/11/2003 | 2003P-0270 | Compassion Over Killing, Inc/Prohibit False and Misleading Labeling | INTERIM RESPONSE 12/05/2003 |
| 06/13/2003 | 2003P-0274 | Abigail Alliance and the Washington Legal Foundation/In re Tier 1 initial Approval Program | INTERIM RESPONSE 12/16/2003 |
| 06/16/2003 | 2003P-0275 | Allergan Inc./Reclassify Cyclosporine (CSA) as Non-antibiotic Drug | DENIED 12/18/2003 |
| 06/17/2003 | 2003P-0276 | CSPI/Establish Interim Acceptable Levels for Acrylamide In Major Food Sources | Interim Response 11/21/2003 |
| 06/17/2003 | 2003P-0277 | Arthur Young/Indicate to Potential Users of a Drug by Means of Labeling Whether Any Product Had Used Human Embryo or Material Derived From Human Embryos in Its Development, Production or Testing |
|
| 06/18/2003 | 2003P-0278 | Cape Cod, Inc./Regulate recombinant and any other previously unlicensed endotoxin detection tests for validation, in-process and finished product endotoxin testing od drugs | INTERIM RESPONSE 12/08/2003 |
| 06/18/2003 | 2003P-0279 | Jerussi Consulting, Inc./Abbreviated New Drug Application for a Topical solution of the three actives fluocinolone acetonide, hydroquinone, and tretinoin |
Denied 04/01/2005 |
| 06/18/2003 | 2003P-0280 | Cape Cod, Inc./Determine that a recombinanat endotoxin tests intended for endotoxin testing of | INTERIM RESPONSE 12/08/2003 |
| 06/19/2003 | 2003P-0283 | Lachman Consultant Services, Inc./ANDA Suitable for Glimepiride Tablets, 8 mg | APPROVED 10/06/2003 |
| 06/19/2003 | 2003P-0284 | Lachman Consultant Services, Inc./Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons |
Withdrawn 01/26/2004 |
| 06/19/2003 | 2003P-0291 | Tim Milburn O.D./Enforce the law and prevent unlaw sale of contact lens | Denied 06/28/2004 |
| 06/20/2003 | 2003P-0288 | Family Care Health Centers/Health Center, be deemed a " pharmacy of an other health care entity" | APPROVED 12/10/2003 |
| 06/23/2003 | 2003P-0289 | Diana E. Kelly/outlaw and prohibit the use of hydrogenated and partially hydrogenated fats in all prepared,manufactured and processed food products intended for human consumption | DENIED 12/19/2003 |
| 06/23/2003 | 2003V-0293 | Lumalaser/Laser Light Show | APPROVED 07/01/2003; Approved 08/25/2006 |
| 06/23/2003 | 2003N-0234 | Crown Cork & Seal Company/Canned Asparagus Deviating From Identity Standard; Temporary Permit for Market Testing |
APPROVED 06/18/2003 Notice of Temproary Marketing Permit June 18, 2003 68FR36567 |
| 06/24/2003 | 2003P-0292 | Samson Medical Technologies, L.L.C./to permit the filing of an ANDA for a Ceftazidime for Injection,UPS,phamacy bulk package in a 100 gram dosage strength packaged in plastic bags that are contained within foil outer wraps |
APPROVED 12/23/2003 |
| 06/26/2003 | 1978N-0036L | C.B. Fleet Company/OTC Laxative | INTERIM RESPONSE 01/05/2004 |
| 06/27/2003 | 2003P-0297 | Peter M. Rothenberg, M.D., MA./Exemption from 510(k) process for an Accessory to Electrode Cable | CLOSED 08/12/2003 Withdrawn August 12, 2003 |
| 06/30/2003 | 2003P-0298 | The Weinberg Group, Inc./Diclofenac Potassium Capusles 25 mg suitable for submission as ANDA | Interim Response 02./03/2004 |
| 06/30/2003 | 2003P-0300 | The Weinberg Group Inc./Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142 voluntarily withdrawn or wtihheld from sale for safety or effectiveness reasons |
Answer 11/18/2003 |
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| July | |||
| 07/03/2003 | 2003P-0450 | PANBIO Limited/De Novo Petition for West Nile Virus IgM Capture ELISA | |
| 07/07/2003 | 2003V-0306 | Visiotopic System LLC/Laser Light Show | Approved 12/04/2006 Terminates after 12/08/2008 |
| 07/07/2003 | 2003P-0307 | Taro Pharmaceuticals /ANDA suitability for a new strength of Warfarin Sodium Tablets, USP 1.5mg | APPROVED 10/06/2003 |
| 07/07/2003 | 1978N-0021 | CTFA/Skin Protectant Drugs for OTC Human Use | Approved in part and denied in part 02/24/2004 |
| 07/07/2003 | 1978N-0021P | CTFA/Skin Protectant Drug Products for OTC Human Use | Approved in part and denied in part 02/24/2004 |
| 07/07/2003 | 1978N-0064 | Revlon, Inc./OTC Antiperspirant | |
| 07/07/2003 | 2003P-0310 | Baldwin Richardson Foods, Co./Nance Pretzel Dip | WITHDRAWN 08/27/2003 |
| 07/08/2003 | 2003P-0304 | Taro Pharmaceuitcals USA, Inc./ANDA suitability for Carbamazepine Oral Suspension USP,200 mg/mL based on the reference-listed drug |
|
| 07/09/2003 | 1978N-0064 | CTFA/OTC Antiperspirant | Approved in part and Denied in part 02/17/2005 |
| 07/15/2003 | 2003P-0315 | CollaGenex Pharmaceuticals/Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug |
Denied 05/13/2005 |
| 07/15/2003 | 2003V-0316 | Imagery Laser/Laser Light Show | APPROVED 11/10/2003; Terminated 11/10/2005 |
| 07/17/2003 | 2003P-0321 | ICN Pharmacuticals, Inc. and Ribapharm /Refrain from approving an Abbreviated New Drug Application (ANDA's) for Riavirin | Interim Response 01/30/2004, Denied 04/06/2004 |
| 07/21/2003 | 2003P-0322 | number not used/number not used | |
| 07/22/2003 | 2003P-0315 | CollaGenex Pharmaceuticals/Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug |
Denied 05/13/2005 |
| 07/23/2003 | 2003P-0331 | Lachman Consultant Services, Inc./ANDA Suitability for Hydrocodone Bitartrate and Ibuprofen Tablets (5 mg/400mg; 7.5 mg/400 mg and 10 mg/400 mg) | Denied 04/01/2005 |
| 07/31/2003 | 2003V-0100 | Beam Bouncers Inc./Laser Light Show | APPROVED 08/29/2003 |
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| August | |||
| 08/06/2003 | 2003P-0275 | Allergan, Inc./Reclassify Cyclosporine (CSA) as Non-antibiotic Drug | DENIED 12/18/2003 |
| 08/06/2003 | 2003V-0354 | Cashier Astroonomical Observers, Inc./Laser light Show | APPROVED 08/27/2003 |
| 08/07/2003 | 2003P-0357 | Beth Rosenshein/Update the Drug/Laboratory Test Interactions section of the prescribing information of all strenghts of Premarin tablets (.3mg, .45mg, .625mg, 1.25mg, 2.5mg) to recognize the decfeased levels of testo |
Approved and denied in part 09/21/2004 |
| 08/11/2003 | 2003P-0358 | Caruso Pharmaceutical Consultation Services/Methenex (Methadone Hydrochloride 40 mg,Naloxone Hydrochloride 2 mg) tablets (effervescent) NDA 17-491/NDA 17-490 withdrawn,discontinued from marketing or withhjeld from sale for safety or efficacy |
|
| 08/11/2003 | 2003V-0359 | OUO Entertainment Corporation/Laser Light Show | APPROVED 08/27/2003 |
| 08/11/2003 | 2003P-0362 | Etymotic Research, Inc./Over-the-counter Hearing Aids | Denied 02/13/2004 |
| 08/11/2003 | 2003P-0363 | GudHear, Inc./Professional and Patient Labeling for Hearing Aid Devices | Denied 02/13/2004 |
| 08/12/2003 | 2003V-0368 | Laser Vision Club Statlk/Laser Artistry Projector | |
| 08/13/2003 | 2003P-0365 | Jerussi Consulting, Inc./Galderma product, solage containing 2% Mequinol, and 0.01% tretinoin, NDA 20-922 can be formulated as a topical solution with the substitution of Hydroquinone at 4% for the 2% mequinol as an ANDA | Denied 12/02/2004 |
| 08/13/2003 | 2003P-0366 | Mattingly, Stanger & Malur, P.C./Amend approval for a nonprescription form of Prilosec (omeprazole magnesium) | Denied 01/21/2005 |
| 08/15/2003 | 2003V-0371 | ECSU Planetarium/ Elizabeth City State University/Laser Light Show | APPROVED 09/10/2003 |
| 08/15/2003 | 2003P-0372 | CollaGenex Pharmaceuticals/Refuse to approve any ANDA for doxycycline hyclate capsules 20mg | Denied 05/13/2005 |
| 08/18/2003 | 2003V-0373 | Eagle River Bowl LLC./Laser Light Show | APPROVED 11/10/2003;Terminated 11/10/2005 |
| 08/19/2003 | 2003V-0374 | Beaming Man/Laser Light Show | APPROVED 08/27/2003 |
| 08/20/2003 | 2003V-0377 | Wild Country/Laser Light Show | APPROVED 10/27/2003; Terminates 10/27/2005 |
| 08/21/2003 | 2003V-0378 | Northway Lanes/Laser Light Show | |
| 08/25/2003 | 1978N-0038 | CTFA & CHPA/Sunscreen Drug Products | |
| 08/25/2003 | 2003P-0387 | Abbott Laboratories/Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products | Interim Response 02/23/2004 |
| 08/26/2003 | 2003P-0398 | International Regulatory Business Consultants, LLC/(ANDA) for Oral Capsule Dosage Form Containing Hydrocodone Bitartrate 5 mg/Butalbital 50 mmg/ Cafferine 40mg/ Acetaminophen 325mg | WITHDRAWN 11/21/2003 |
| 08/27/2003 | 2003P-0388 | Lachman Consultant Services, Inc./ANDA Suitability for Metformin Hydrochloride Extended-Release (XR) Tablets, 1000 mg | APPROVED 12/23/2003 |
| 08/27/2003 | 2003V-0389 | I T Maintenance/Laser Display Device | |
| 08/28/2003 | 2003V-0394 | XO/Laser Light Show | APPROVED 09/11/2003 |
| 08/28/2003 | 2003P-0393 | PharmaForce, Inc./Diazepam Injection USP, 5 mg/mL, 1-mL,(ANDA No. 72-079), by Abbott laboratories, Inc., has been voluntarily withdrawn or withheld from sale for safety or efficacy reasons | Answer 04/02/2004 |
| 08/28/2003 | 1978N-0038 | CTFA and CHPA/Sunscreen Drug Products | |
| 08/28/2003 | 2003V-0396 | Kaanapali Beach Hotel/Laser LIght Show | APPROVED 10/02/2003; Terminates 10/02/2005 |
| 08/28/2003 | 2003V-0395 | Lunar Bowl/Laser Light Show | APPROVED 09/11/2003 |
| Top | |||
| September | |||
| 09/03/2003 | 2003P-0408 | TorPharm, Inc./Request for Immediate Withdrawal of Final Approval of Syntheon's NDA No. 21-299 for Asimia (Paroxetine Mesylate) 10 mg, 20 mg, 30 mg and 40 mg Tablets | DENIED 10/14/2003 |
| 09/03/2003 | 2003P-0409 | Orthopedic Surigical Manufacturers Assn./Reclassification for Moblie Bearing Knees from Class III and Class II | |
| 09/04/2003 | 2003P-0413 | Lachman Consultant Services, Inc./Hyrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg combination drug product is suitable for submision as a ANDA | Closed 11/02/2004 |
| 09/04/2003 | 2003P-0414 | Lachman Consultant Services, Inc./Hydrocondone Bitartrate and Acetaminophen tablets 5 mg/300 mg as an ANDA | APPROVED 11/23/2004 |
| 09/10/2003 | 2003V-0423 | Avampato Discovery Meseum/Laser Light Show | APPROVED 10/10/2003; Terminates 10/10/2005 |
| 09/11/2003 | 2003V-0426 | Celebration City/Laser Light Show | APPROVED 10/02/2003; Approved 06/08/2005; Terminated 10/02/2008; Approved 06/26/2006 |
| 09/12/2003 | 2003V-0428 | Cunningham Products Resources/Laser Light Show | Approved 11/09/2005 |
| 09/15/2003 | 2003V-0430 | Laser Magic Productions/Laser Light Show | |
| 09/15/2003 | 2003V-0431 | Laserworks/Laser Light Show | |
| 09/15/2003 | 2003V-0433 | Vandenberg Community Center/Laser Light Show | APPROVED 10/27/2003; Terminates 10/27/2005 |
| 09/22/2003 | 2003V-0435 | Warner Bros. Entertainment Inc./Laser Light Show | Approved 01/22/2004; Terminates 01/22/2006 |
| 09/22/2003 | 2003P-0436 | Anabolic Laboratories, Inc./(ANDA) containing 300 mg Acetaminophen/ 5 mg Hydrocodone, 300 mg Acetaminophen/ 7.5 mg Hydrocodone, 300 mg Acetaminophen/ 10 mg Hydrocodone | CLOSED 10/10/2003 Petition is incomplete as submitted |
| 09/23/2003 | 2003P-0439 | Dominic J. Morgan/Elective Refractive Eye Surgery with Premarket Approvals (PMAs) | |
| 09/24/2003 | 2003V-0440 | Area 54 DJ Co./Laser Light Show | |
| 09/24/2003 | 2003P-0441 | Nabeal M. Saif, R.Ph./ANDA suitability for metoprolol tartrate 12.5 mg tablets | Denied 10/15/2004 |
| 09/24/2003 | 2003P-0438 | Russel J. Thomsen, MD/change the regulatory status of prenatal listening devices commonly called 'Doppler Fetoscopes' under 21 CFR 5.10 | Denied 06/14/2004 |
| 09/24/2003 | 2003P-0437 | Public Citizen Litigation Group/refrain from covering the General and Plastic Surgery Devices panel of the Medical Devices Advsory committee on 10/14/03 | Closed 01/28/2005 |
| 09/25/2003 | 2003P-0453 | King & Spalding LLP/Abbreviated new drug applications (ANDAs) suitability for hydrocodone bitartrate | Interim Response 02/04/2004 |
| 09/29/2003 | 2003V-0454 | CAO Group Inc./Variance for Denlaser 800 | |
| 09/29/2003 | 2003V-0473 | Carl Zeiss Jena GMBH/Variance Laser Display Device, JENOPTIK LOS: JenLas WHiteLight; Projector | PENDING 10/10/2003 |
| 09/30/2003 | 2003V-0459 | NEA Inc./Laser Light Show | |
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| October | |||
| 10/01/2003 | 2003P-0460 | Anabolic Laboratories, Inc./ANDA Suitability 200 mg Carisoprodol and 325 mg of Acetaminophen combination drug product ; 200 mg Carisprodol, 325 mg Acetaminophen, and 16 mg Codeine Phosphate drug product | Interim Response 02/04/2004 |
| 10/01/2003 | 2003P-0461 | Anabolic Laboratories, Inc./Abbreviation New Drug Application (ANDA) suitablility for 7.5 mg of Cyclobenzaprine HCI | Approved 10/15/2004 |
| 10/02/2003 | 2003P-0464 | Lachman Consultant Services, Inc./ANDA for Clonazepam Oral Solution | Approved 10/18/2005 |
| 10/08/2003 | 2003P-0469 | Eugene G. Keller, R.Ph., FACA/ANADA Suitability for Ivermectin Hard-Chew Anthelmintic for (non- food) Horses | APPROVED 12/04/2003 |
| 10/08/2003 | 2003P-0477 | Endotec/Expedite the revocation of determination of the application of the AIP | Interim Response 03/26/2004 |
| 10/10/2003 | 2003P-0475 | International Regulatory Business Consultants, Ltd./Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA | Interim Response 02/04/2004 |
| 10/15/2003 | 2003P-0479 | The City of Springfield, Massachusetts/Allow importation of Canadian versions of drugs that are approved to the United States | Denied 08/06/2004 |
| 10/15/2003 | 2003V-0480 | Laser Design Productions Inc./Laser Light Show | Approved 11/03/2003 Moved to 2003V-0131 |
| 10/15/2003 | 2003V-0131 | Laser Design Productions Inc./Laser Light Show | Approved 11/03/2003 |
| 10/16/2003 | 1978N-0038 | Tanning Research Laboratories, Inc./Sunscreen Drug Products | Inerim Response 05/05/2004 |
| 10/16/2003 | 2003P-0162 | JM Investment Inc./Import Canadian food products taht do not meeting labeling requirements | Pending |
| 10/20/2003 | 2003V-0484 | Pulslight Co./Laser Light Show | |
| 10/20/2003 | 2003V-0485 | DBA Posh Nightclub Lorenzo Entertainment/Laser Light Show | |
| 10/21/2003 | 1997D-0411 | GME & GMIA/(BSE) in Products for Human Use; Guidance for Industry. | |
| 10/23/2003 | 2003V-0489 | Discovery Beach Restaurant & Club Inc./Laser Light Show | APPROVED 11/10/2003; Terminates 11/10/2005 |
| 10/24/2003 | 2003P-0494 | Baxter Healthcare Corporation/Not approve any new drug application (NDA) for a hyaluronidase product unless the conditions set forth in the petition are satisfied | Denied 05/05/2004 |
| 10/27/2003 | 2003V-0495 | Lasertek F/X/Laser Light Show | |
| 10/29/2003 | 2003V-0500 | WBII TV/Projector for a Laser Light Show | |
| 10/30/2003 | 2003P-0501 | Lachman Consultant Services, Inc./Pyridostigmine Bromide Tablets, 30mg for the of myasthenia gravis (ANDA) voluntarily withdrawn from sale for safety or efficacy reasons | Answer 06/22/2005 |
| 10/31/2003 | 2003P-0505 | Lachman Consultant Services, Inc./ANDA for Acetaminophen, Caffeine and Orphenadrine Citrate Tablets | Withdrawn 07/07/2004 |
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| November | |||
| 11/04/2003 | 2003V-0510 | InterVision/Spectra Scan Laser Systems Cat's Meow Projector | Approved 02/26/2004 |
| 11/04/2003 | 2003V-0514 | Heritage Planetarium/Laser Light Show | |
| 11/05/2003 | 2003V-0515 | Full House Productions L. L. C./Laser Display Device | |
| 11/05/2003 | 2003V-0516 | Vanderbilt Museum Planetarium/Laser Light Show | |
| 11/05/2003 | 2003P-0517 | Alpharma Inc./Determine that Pennifield is not eligible for interim marketing for bacitracin MD | |
| 11/05/2003 | 2003P-0518 | Wyeth Pharmaceuticals/Refrain from approving any Abbreviated New Drug Application for sirolimus with Rapamune (sirolimus) | Approveed 09/20/2004 |
| 11/06/2003 | 2003P-0519 | Abbott Laboratories/ANDA Suitability for Ondansetron Hydrochloride Injection and Ondansetron Hydrochloride Injection Premixed |
Withdrawn 03/22/2004 |
| 11/06/2003 | 2003P-0511 | Public Citizen Health Research Group/refrain from completing the review of the PMA submitted by Inamed Corporation(Inamed) for McGhan silicone gel-filled breast implants | DENIED 12/04/2003 |
| 11/10/2003 | 2003P-0520 | NUMBER NOT USED/Laser Light Show | |
| 11/10/2003 | 2003V-0521 | Heritage Planetarium/Laser Light Show | Approved 12/21/2005 |
| 11/12/2003 | 2003P-0523 | Karen A. Sisson/ANADA Suitability Petition for Ivermectin/Praziquantel Granule/Crumble Anthelmintic for Horses |
APPROVED 12/04/2003 |
| 11/17/2003 | 2003V-0527 | Carnaval Night Club/Laser Light Show | APPROVED 12/15/2003 |
| 11/18/2003 | 2003P-0530 | Chemically Associated Neurological Disorders/Silicone Gel-filled Breast Implants | DENIED 12/04/2003 |
| 11/19/2003 | 2003P-0531 | Fulcrum Inc./Issue a report providing the necessary information on pill weight tolerances and/or variations caused by reformulations | Denied 08/17/2005 |
| 11/21/2003 | 2003P-0534 | Lachman Consultant Services, Inc./Glyburide and metformin hydrochloride Oral Solution 1.25 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10 | Approved 07/30/2004 |
| 11/25/2003 | 2003V-0540 | Colossal Mobile Sound/Laser Light Show | Approved 02/24/2004 |
| 11/26/2003 | 2003V-0541 | Crobar/Laser Light Show | APPROVED 12/23/2003 |
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| December | |||
| 12/01/2003 | 2003P-0544 | Center for Food Safety & Public Citizen, Critical Mass/Modify existing food additive regulation with respect to the irradiation of ground beef byproducts | WITHDRAWN 12/09/200312/01/2003 |
| 12/01/2003 | 2003V-0543 | Pulse - Mobile DJ/A Projector for a Laser Light Show | APPROVED 12/23/2003 |
| 12/01/2003 | 1992N-0297 | Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987, Drug Amds of 1992 | Approved 03/30/2004 |
| 12/01/2003 | 1988N-0258 | Pharmaceutical Distributors Association/Prescription Drug Marketing Act of 1987; Guideline | Approved 03/30/2004 |
| 12/03/2003 | 2003N-0361 | Pharmaceutical Distributors Association/Anti-Counterfeit Drug Initiative | PENDING 12/03/2003 |
| 12/04/2003 | 2003V-0546 | The Ark/JGET/Laser Light Show | APPROVED 12/22/2003, Terminates 12/22/2005 |
| 12/08/2003 | 2003P-0548 | GrayCary/Determination whether Dexamethasone Acetate Injection withdrawn for Safety Reasons |
Answered 09/23/2004
|
| 12/09/2003 | 2003V-0550 | Whatergy Inc./Laser Light Show | Approved 02/04/2004; Terminates on 02/04/2006 |
| 12/09/2003 | 2003P-0551 | Alphapham Pty Ltd/Citalopram Hydrobromide Capsules | Approved 03/29/2005 |
| 12/10/2003 | 2003P-0555 | Committee for Truth in Psychiatry/Maintain the Electroconvulsive Therapy Device in Class III for All Indications | Answer 09/03/2004 |
| 12/11/2003 | 2003P-0556 | Hyman, Phelps & McNamara, PC/ANDA for Dihydroergotamine Mesylate Injection | Denied 04/01/2005 |
| 12/12/2003 | 2003P-0552 | Jurox PTY, limited/ANADA for a generic new animal drug caroprofen | Approved 03/19/2004 |
| 12/12/2003 | 2003P-0530 | J Huffman/Silicone Gel-filled Breast Implants | PENDING 12/12/2003 |
| 12/12/2003 | 2003P-0479 | State of Vermont, Agency of Administration/Allow importation of Canadian versions of drugs that are approved to the United States | Denied 08/04/2004 |
| 12/18/2003 | 2003V-0563 | Rowan University, Department of Physics & Astronomy/Laser Light Show | PENDING 12/18/2003 |
| 12/19/2003 | 2003V-0566 | True Lasers LLC./Laser Light Show | PENDING 12/19/2003 |
| 12/23/2003 | 2003P-0576 | Stockbridge Family Medicine/Warning Label for all Food Products Which Contain Gluten | Closed 05/06/2004 |
| 12/24/2003 | 2003P-0574 | American Bakers Association et al/Regulatory limit for Listeria monocytogenes in ready-to-eat foods that do not support its growth | PENDING 12/24/2003 |
| 12/30/2003 | 2004P-0008 | Cancer Action NY/Protection from Chlorinated Dibenzo-p-dioxins and Chlorodibenzofurans | |
| 12/31/2003 | 2004P-0004 | Environmental Working Group/Request for correction of FDA'S ''Advice for women who are pregnant, or who might become pregnant, and nursing mothers, about avoiding harm to your baby or young child from mercury in fish and shellf | PENDING 12/31/2003 |
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