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U.S. Department of Health and Human Services

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01/06/2003 2003P-0006 Lachman Consultant Services, Inc./Determine if Levorphanol Tartrate withdrawn for safety reaso Withdrawn 4/20/06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01/30/2003 2003P-0039 Orphan Medical/Policy regarding users fee and Orphan Drug Withdrawn 08/11/2006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
Top      
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
Top      
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
Top      
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  
Top      
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
Top      
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
Top      
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
Top      
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
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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  
Top      
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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