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DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY
Center for Drug Evaluation and Research, Main Page
www.fda.gov/cder/orange/bioavail.htm - Posted: 02-17-2000 - Cached

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY ...
... ASPIRIN; BUTALBITAL; CAFFEINE CAPSULE OR TABLET; ORAL 325MG; 50MG; 40MG 650MG; 50MG;
40MG, ASPIRIN; CAFFEINE; CARISOPRODOL TABLET; ORAL 160MG; 32MG; 200MG. ...
www.fda.gov/cder/ob/docs/preface/ecbioava.htm - 01-06-2006 - Cached

FDA Advises Consumers about Recalled Drugs from Able Laboratories
FDA Advises Consumers about Recalled Drugs from Able Laboratories
www.fda.gov/bbs/topics/NEWS/2005/NEW01182.html - Updated: 06-17-2005 Posted: 05-27-2005 - Cached

FDA Enforcement Report
... Quantity: 26,262 bottles were distributed. Reason: Lack of assurance of sterility. ----
Product: (a) Carisoprodol Compound Tablets (Carisoprodol/Aspirin, 200 ...
www.fda.gov/bbs/topics/ENFORCE/ENF00042.html - 02-18-1998 - Cached

FDA Enforcement Report
... COSMETICS NONE HUMAN DRUGS AND BIOLOGICS Class I - Product: Goldline brand Carisoprodol
Tablets, 350 mg., in 100 tablet bottles, an Rx oral centrally ...
www.fda.gov/bbs/topics/ENFORCE/ENF00077.html - 02-18-1998 - Cached
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OGD Suitability Tracking Reports (Sorted by Drug Name)
... CARISOPRODOL 200 MG, 01P-0526/CP1 ATLEY PHARMACEUTICALS, INC. ... CARISOPRODOL 200 MG
ACETAMINOPHEN 325 MG, 03P-0460/CP1 ANABOLIC LABORATORIES, INC. ...
www.fda.gov/cder/ogd/DrugSortpage.htm - Large File: 101k - 07-07-2006 - Cached

Paragraph IV Patent Certifications
... Carisoprodol/ Aspirin, Tablets, 200 mg/ 325 mg, Soma Compound, Carisoprodol/ Aspirin/
Codeine, Tablets, 200 mg/ 325 mg/ 16 mg, Soma Compound with Codeine, ...
www.fda.gov/cder/ogd/ppiv.htm - Large File: 101k - 09-15-2006 - Cached

Drug Approvals for June 2001
... Original Abbreviated Application # 040421 Approval Date: 21-JUN-01 Trade Name:
CARISOPRODOL Dosage Form: TABLET Applicant:ABLE LABORATORIES, INC Active ...
www.fda.gov/cder/da/da0601.htm - 01-17-2006 - Cached
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Drug Abuse Advisory Committee Meetings
... cessation. Topic: Soma (carisoprodol), NDA 11-792 Topic: Consideration
of DEA petition regarding scheduling of carisoprodol. Date ...
www.fda.gov/cder/audiences/acspage/drugabusemeetings1.htm - 01-17-2006 - Cached

[PDF] DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD ...
... comand has determined that the drug products, Viagra?(Sildenafil hydrochloride),
Prozac?(Fluoxetine hydrochloride), Soma?(Carisoprodol) and numerous ...
www.fda.gov/cder/warn/cyber/2001/Cyber094.pdf - 03-27-2001 - Text Version

MedWatch - June 2006 Safety-Related Drug Labeling Changes ...
FDA, MedWatch, June 2006 Safety Related Labeling Changes
www.fda.gov/medwatch/safety/2006/jun06.htm - Large File: 101k - Updated: 08-15-2006 Posted: 08-15-2006 - Cached
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[PDF] ANDA 40-283 December 29, 1998 Amide Pharmaceutical, Inc. Attention ...
... new drug application dated October 27, 1997, submitted pursuant to Section 505(j)
of the Federal Food, Drug, and Cosmetic Act, for Carisoprodol, Aspirin and ...
www.fda.gov/cder/foi/appletter/1998/40283ltr.pdf - 12-30-1998 - Text Version

[PDF] ANDA 40-397 September 21, 2000 Corepharma LLC Attention ...
... drug application dated December 1, 1999, submitted pursuant to Section 505(j) of
the Federal Food, Drug, and Cosmetic Act (Act), for Carisoprodol Tablets USP ...
www.fda.gov/cder/foi/appletter/2000/40397ltr.pdf - 10-31-2000 - Text Version
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Drug Approvals - C
... Carisoprodol, Aspirin and Codeine Phosphate Tablets USP, 200 mg/325 mg/16 mg, Rx,
Amide Pharmaceutical, Inc. ANDA 40-283, 12/29/98, 12/29/98, 9/27/02. ...
www.fda.gov/cder/approval/c.htm - Large File: 101k - 01-06-2006 - Cached

[TEXT] [Federal Register: November 19, 1998 (Volume 63, Number 223)] ...
... 874..... Carisoprodol Compound Tablets 88-620..... ...
www.fda.gov/ohrms/dockets/98fr/111998b.txt - 02-11-1999 - Cached

[PDF] L:\DRUG FILES\B\Benazepril\1-year post-pediatric postmarketing ...
... in a two year old male who may have taken one or more of three medications prescribed
for his grandmother; rosiglitazone, benazepril and/or carisoprodol. ...
www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4089b1_01_02_benazepril.pdf - 02-11-2005 - Text Version

[PDF] 1 FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND ...
Page 1. _梍 .=?.- _-?.. . 1 FOOD AND DRUG ADMINISTRATION CENTER
FOR DRUG EVALUATION AND RESEARCH JOINT MEETING OF THE ...
www.fda.gov/ohrms/dockets/ac/99/transcpt/3525t1a.pdf - 08-16-1999 - Text Version
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[PDF] MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH ...
... 6 . 40-611 PREDNISONE TABLETS USP, 1 MG TRIGEN LABORATORIES, INC. AP'd on: 6/6/2005
7 . 40-576 CARISOPRODOL TABLETS USP, 350 MG NEIL LABORATORIES, INC. ...
www.fda.gov/ohrms/dockets/dockets/90s0308/90s-0308-rpt0756.pdf - 07-26-2005 - Text Version

Generic Approvals - June 2005
... 6/2/2005. 6, 40-611, PREDNISONE TABLETS USP, 1 MG, TRIGEN LABORATORIES, INC.
6/6/2005. 7, 40-576, CARISOPRODOL TABLETS USP, 350 MG, NEIL LABORATORIES, INC. 6/ ...
www.fda.gov/cder/ogd/approvals/ap0605.htm - 04-25-2006 - Cached

Able Laboratories Inc. Warning Letter
Able Laboratories inc., warning letter, April 19, 2004
www.fda.gov/foi/warning_letters/g4651d.htm - 05-11-2004 - Cached