http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_DEC_1998.HTML 9-Dec-1998 TRIDIL INJECTION Nitroglycerine Injection 18-537 S-015 Faulding 9-Dec-1998 EFFEXOR Venlafaxine Hydrochloride 20-151 S-009 Wyeth Ayerst 9-Dec-1998 NITROGLYCERIN IN DEXTROSE Nitroglycerin 19-970 S-009 Baxter Hlthcare 9-Dec-1998 REBETOL Interferon Alfa-2b, Recombinant Capsules 20-903 S-002 Schering Plough Res 9-Dec-1998 BRETHINE INJECTION Terbutaline Sulfate Injection 18-571...
FDA Drug Approvals List April 2002 JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): HALOPERIDOL OTC/RX Status: RX Application #: 011340 Labeling Supplement #: 016 To Original New Drug Application Approval Date: 17-APR-02 Trade Name: CERUMENEX Dosage Form: SOLUTION Applicant: PURDUE FREDERICK CO Active Ingredient(s): TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATE OTC/RX Status: OTC Application #: 010596...
Prescription and OTC Drug Product List 6/2002 ACTHAR GEL -D- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 JUL DISC -A- @ 40 UNITS/ML N08372 006 JUL DISC DIATRIZOATE SODIUM SOLUTION; ORAL, RECTAL HYPAQUE -D- AMERSHAM HLTH 40% N11386 003 JUL DISC -A- @ 40% N11386 003 JUL DISC DICLOFENAC SODIUM GEL; TOPICAL SOLARAZE -A- + BIOGLAN PHARMA 3% N21005 001 OCT 16, 2000 JUL CAHN -D- + BIOGLAN PHARMA PLC 3% N21005 001 OCT 16, 2000 JUL CAHN...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
C:\Data\My Documents\NDA 18948\AP S022. w.draft labeling 4.5.02. doc\ ..doc NDA 18- 948/ S- 022 NDA 19- 257/ S- 010 NDA 20- 182/ S- 008 Page 3 CARNITOR ® (levocarnitine) CARNITOR ® (levocarnitine) Tablets (330 mg) CARNITOR ® (levocarnitine) Oral Solution (1 g per 10 mL multidose) For oral use onlyCARNITOR ® , calculated after...
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http://www.fda.gov/cder/foi/appletter/2001/75567ltr.pdf ANDA 75- 567 March 29, 2001 Bedford Laboratories Attention: Shahid Ahmed 270 Northfield Road Bedford, OH 44146 Dear Sir: This is in reference to your abbreviated new drug application dated January 12, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Levocarnitine Injection USP, 200 mg/ mL (packaged in 500 mg/ 2.5 mL, and 1 g/ 5...
http://www.fda.gov/cder/foi/appletter/2001/75567ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/2001/75861ltr.pdf ANDA 75- 861 June 22, 2001 Luitpold Pharmaceuticals, IncLevocarnitine Injection USP, 200 mg/ mL, (packaged in 500 mg/ 2.5 mL,...
http://www.fda.gov/cder/foi/appletter/2001/75861ltr.pdf page 1
http://www.fda.gov/cder/foi/appletter/2001/75881ltr.pdf ANDA 75- 881 March 29, 2001 Gensia Sicor Pharmaceuticals, IncLevocarnitine Injection USP, 200 mg/ mL (packaged in 500 mg/ 2.5 mL, 1 g/ 5 mL, and 2...
http://www.fda.gov/cder/foi/appletter/2001/75881ltr.pdf page 1
Prescription and OTC Drug Product List 3/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 3: January-March 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ATORVASTATIN CALCIUM CAPSULE; ORAL TABLET; ORAL - ADD - BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE LIPITOR - ADD - PHOSPHATE ...
DDPA August 1995 74-462 CAPTOPRIL COPLEY PHARMA CAPTOPRIL 24-AUG-95 (TABLET) CANTON, MA 12.5MG 02021 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) 74-505 CAPTOPRIL WESTWARD CAPTOPRIL 31-AUG-95 (TABLET) EATONTOWN, NJ 12.5MG 07724 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-766 ZOCOR MERCK SIMVASTATIN 01-AUG-95 (TABLET) WEST POINT...
1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information OfficeCarnitor Tablets/Levocarnitine [640 KB] Sigma-Tau Pharmaceuticals, Inc
Patent and Exclusivity Terms PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE I-230 IN COMBINATION WITH CISPLATIN, FOR THE FIRST-LINE TREATMENT OF NON-SMALL CELL LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY AND/OR RADIATION I-231 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR CHEMOTHERAPY I-232 TREATMENT OF RECURRENT MUCOCUTANEOUS...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 5/21/99 6/1/99 June Agenerase (amprenavir) Glaxo Wellcome DDMAC 6/4/99 6/9/99 Avandia (rosiglitazone maleate) tablets SmithKline Beecham DDMAC 6/29/99 7/1/99 Lipitor (atrovastatin calcium) tablets Parke-Davis DDMAC 6/22/99 6/29/99 Navelbine (vinorelbine) for injection Glaxo Wellcome DDMAC 6/21/99 8/6/99 Site Inspection-Warning Letter Solvay Pharmaceuticals DMPQ 6/23/99 7/2/99...
