Application 075772
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 15MG/ML | No | No |
| 002 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE;INJECTION | 30MG/ML | No | No |
| 003 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | INJECTABLE; INJECTION | 60MG/2ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0641-6041 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6041 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6041 | Ketorolac Tromethamine | Ketorolac Tromethamine | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6041 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6042 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6042 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6042 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6042 | Ketorolac Tromethamine | Ketorolac Tromethamine | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6043 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6043 | Ketorolac Tromethamine | Ketorolac Tromethamine | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0641-6043 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0641-6043 | Ketorolac Tromethamine | Ketorolac Tromethamine | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 50090-4583 | Ketorolac Tromethamine | Ketorolac Tromethamine | A-S Medication Solutions | ANDA | Current |
| 50090-4583 | Ketorolac Tromethamine | Ketorolac Tromethamine | A-S Medication Solutions | ANDA | Current |
| 52584-084 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | General Injectables and Vaccines, Inc. | ANDA | Current |
| 70518-1239 | Ketorolac Tromethamine | Ketorolac Tromethamine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1239 | Ketorolac Tromethamine | Ketorolac Tromethamine | REMEDYREPACK INC. | ANDA | Current |