http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
FDA Drug Approvals List November 2001 REDDY'S LABORATORIES LIMITED Active Ingredient(s): IBUPROFEN OTC/RX Status: RX Original Abbreviated Application # 075347 Approval Date: 16-NOV-01 Trade Name:OMEPRAZOLE Dosage Form: CAPSULE Applicant: ANDRX PHARMACEUTICALS, INC Active Ingredient(s): OMEPRAZOLE OTC/RX Status: RX Original Abbreviated Application # 075682 Approval Date: 14-NOV-01 Trade Name:IBU Dosage Form: TABLET...
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
http://www.fda.gov/cder/foi/label/2001/19221s26lbl.pdf In using VASERETIC, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with VASERETIC ® 7843635 (Enalapril Maleate - Hydrochlorothiazide) 4 renal impairment or collagen vascular disease, and that available data are insufficient to show that ...
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FDA Drug Approvals List- February 1999 Applicant: CONNETICS CORP Active Ingredient(s): BETAMETHASONE VALERATE OTC/RX Status: RX Indication(s):For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp Original Application #: 020969 Approval Date: 25-FEB-99 Trade Name: UVADEX Chemical Type: 3 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: THERAKOS INC...
http://www.fda.gov/cder/foi/appletter/2001/75788TA.pdf page 1
http://www.fda.gov/cder/foi/appletter/2001/75727TA.pdf ANDA 75- 727 June 8, 2001 TEVA Pharmaceuticals USA Attention: Philip Erickson 1090 Horsham Road PEnalapril Maleate and Hydrochlorothiazide ...
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FDA Drug Approvals List- October 1998 Drug Approvals for October 1998 Definitions and Notes October 1998 Original New Drug Applications Original Application #: 020926 Approval Date: 30-OCT-98 Trade Name: RENAGEL Chemical Type: 1 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: GELTEX PHARMACEUTICALS INC Active Ingredient(s): SEVELAMER HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the reduction of serum...
DDPA July 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-379 CAVERJECT UPJOHN ALPROSTADIL 06-JUL-95 (INJECTABLE) KALAMAZOO, MI 0.01MG/VIAL (3 P) 49001 0.02MG/VIAL (PROSTAGLANDIN) [TREATMENT...
