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

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