Application 075784
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products
| 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 |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1594 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 55154-9366 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health, Inc. | ANDA | Current |
| 55154-9366 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | ANDA | Current |
| 55154-9368 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health, Inc. | ANDA | Current |
| 55154-9368 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health, Inc. | ANDA | Current |
| 55154-9368 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health, Inc. | ANDA | Current |
| 55154-9368 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | ANDA | Current |
| 55154-9398 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-9398 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-9398 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health 107, LLC | ANDA | Current |
| 55154-9398 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 55154-9398 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Cardinal Health | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-161 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-162 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Fresenius Kabi USA, LLC | ANDA | Current |
| 70518-1091 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-1340 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3369 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 70518-3369 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | REMEDYREPACK INC. | ANDA | Current |
| 71872-7185 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | Medical Purchasing Solutions, LLC | ANDA | Current |