"65FR78494" indicates a notice of some kind was published in the Federal Register
(FR) for a particular date. The FR can be found at http://www.fda.gov/ohrms/dockets/ and then go to the Federal Register section.
Interim Response is not a final decision on the petition.
| 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 |
| Top |
| 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 |
| Top |
| 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 |
| Top |
| 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 |
| Top |
| 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 |
| Top |
| 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 |
| Top |
| 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 |
| Top |
| December 2004 |
| 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 |
