FDA Approval Activities for this Drug…

ACULAR (ketorolac tromethamine) ophthalmic solution, 0.5% Allergan NDA 19700/S18 7/6/01 6/16/03 ACULAR LS (ketorolac tromethamine) ophthalmic solution, 0.4% Allergan, NDA 21-528 5/30/03 6/9/03 6/9/03 10/15/03 Acular (Ketorolac Tromethamine Ophthalmic Solution) Sterile & Preservative-Free Sterile, 5% Allergan, NDA 19-700/S-019 & 20-811/S-003 Ketorolac Tromethamine Ophthalmic Solution, 5%, Novex Pharma ANDA 76-109 5/30/03 Ketorolac Tromethamine Injection USP, 15 mg/mL & 30 mg/mL, American Pharmaceutical Partners ANDA 75-784 1/14/02 Ketorolac Tromethamine Injection USP, 15 mg/mL & 30 mg/mL, Apotex Corp. ANDA 75-631 6/29/01 Ketorolac Tromethamine Injection USP, 30 mg/mL, Apotex Corp. ANDA 75-626 7/24/01 Ketorolac Tromethamine Injection USP, 15 mg/mL & 30 mg/mL, Apothecon, ANDA 75-348 11/29/00 2/28/01 Ketorolac Tromethamine Injection USP,15 mg/mL Baxter Pharmaceutical Products, ANDA 75-299 11/3/99 12/30/99 Ketorolac Tromethamine Injection USP,15 mg/mL Bedford ANDA 75-230 11/25/99 12/30/99 Ketorolac Tromethamine Injection USP,15 mg/mL (1 mL fill, Carpuject) & 30mg/mL (1 mL & 2 mL fill, Carpuject). Abbott ANDA 74-993 1/27/97 1/27/97 Ketorolac Tromethamine Tablets USP, 10 mg Sidmak ANDA 75-284 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE Abbott 074801 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE Abbott 074993 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE Abbott 074993 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Abbott 074801 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Abbott 074802 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Abbott 075784 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE AM PARTNERS 075784 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE AM PARTNERS 075631 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE Apotex 075626 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Apotex 075631 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Apotex 075299 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE Baxter CORP 075299 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Baxter CORP 075222 KETOROLAC TROMETHAMINE Injection 15MG/ML KETOROLAC TROMETHAMINE Bedford 075222 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Bedford 075228 KETOROLAC TROMETHAMINE Injection 30MG/ML KETOROLAC TROMETHAMINE Bedford 019698 KETOROLAC TROMETHAMINE Injection 15MG/ML TORADOL ROCHE PALO 019698 KETOROLAC TROMETHAMINE Injection 30MG/ML TORADOL ROCHE PALO 021528 KETOROLAC TROMETHAMINE Solution/Drops; Ophthalmic 0.4% ACULAR LS ALLERGAN 019700 KETOROLAC TROMETHAMINE Solution/Drops; Ophthalmic 0.5% ACULAR ALLERGAN 020811 KETOROLAC TROMETHAMINE Solution/Drops; Ophthalmic 0.5% ACULAR PRESERVATIVE FREE ALLERGAN 074761 KETOROLAC TROMETHAMINE Tablet; 10MG KETOROLAC TROMETHAMINE Mylan 075284 KETOROLAC TROMETHAMINE Tablet; 10MG KETOROLAC TROMETHAMINE Pliva 019645 KETOROLAC TROMETHAMINE Tablet; 10MG TORADOL ROCHE PALO 074754 KETOROLAC TROMETHAMINE Tablet; 10MG KETOROLAC TROMETHAMINE Teva 074955 KETOROLAC TROMETHAMINE Tablet; 10MG KETOROLAC TROMETHAMINE Watson Ketorolac Tromethamine Injection, Baxter HealthCare, Approval Ketorolac Tromethamine Injection, Amphastar Pharmaceuticals, Approval Ketorolac Tromethamine Injection, Apotex Corp., Approval | Acular (ketorolac tromethamine) ophthalmic solution, Allergan, Package Change & Labeling Revision

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