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… 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   For the latest approval information, locate this drug using this index.