Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Butorphanol Tartrate Injection USP, 1mg/ml and 2mg/ml single dose vials, Bedford ANDA 75-045 8/12/98 8/14/98 Butorphanol Tartrate Injection USP, 2mg/ml and 10mg/ml multiple dose vials, Bedford ANDA 75-046 8/12/98 8/14/98 9/25/02 Butorphanol Tartrate Injection USP (Preservative-Free), 1 mg/mL and 2 mg/mL, Faulding Pharmaceutical ANDA 75-170 9/28/98 9/28/98 9/25/02 Butorphanol Tartrate Injection USP (Preservative-Free), 1 mg/mL and 2 mg/mL, Meridian Medical Technologies, ANDA 75-342 11/4/99 12/30/99 Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/mL, Abbott ANDA 75-559 3/20/00 3/21/00 Butorphanol Tartrate Injection USP, 2 mg/mL, Apotex Corp. ANDA 75-697 10/23/01 Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/mL, Apotex Corp. ANDA 75-695 10/23/01 Butorphanol Tartrate Nasal Spray, 10 mg/mL, Roxane, ANDA 75-824 3/12/02 4/10/03 Butorphanol Tartrate Nasal Spray, 10 mg/mL (1mg/spray), ESI Lederle ANDA 75-759 8/8/01 Butorphanol Tartrate Nasal Spray, 10 mg/mL, Novex Pharma ANDA 75-499 Stadol NS (butorphanol tartrate) Nasal Spray Bristol-Myers Squibb Company NDA 19-890/S-017 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Abbott 075559 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE Abbott 074620 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Abbott 074620 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Abbott 075559 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE Abbott 074626 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Abbott 075695 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Apotex 075695 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Apotex 075697 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE Apotex 017857 BUTORPHANOL TARTRATE Injection 1MG/ML STADOL PRESERVATIVE FREE APOTHECON 017857 BUTORPHANOL TARTRATE Injection 2MG/ML STADOL PRESERVATIVE FREE APOTHECON 017857 BUTORPHANOL TARTRATE Injection 2MG/ML STADOL APOTHECON 075045 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Bedford 075045 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Bedford 075046 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE Bedford 075170 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Faulding 075170 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE PRESERVATIVE FREE Faulding 075342 BUTORPHANOL TARTRATE Injection 1MG/ML BUTORPHANOL TARTRATE MERIDIAN MEDCL TECHN 075342 BUTORPHANOL TARTRATE Injection 2MG/ML BUTORPHANOL TARTRATE MERIDIAN MEDCL TECHN 019890 BUTORPHANOL TARTRATE Spray, Metered; Nasal 1MG/SPRAY STADOL BRISTOL MYERS SQUIBB 075759 BUTORPHANOL TARTRATE Spray, Metered; Nasal 1MG/SPRAY BUTORPHANOL TARTRATE Mylan 075499 BUTORPHANOL TARTRATE Spray, Metered; Nasal 1MG/SPRAY BUTORPHANOL TARTRATE Novex 075824 BUTORPHANOL TARTRATE Spray, Metered; Nasal 1MG/SPRAY BUTORPHANOL TARTRATE Roxane   For the latest approval information, locate this drug using this index.