Application 203242
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 76045-104 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-104 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-104 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-104 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-104 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-105 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-105 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-105 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-105 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-105 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-107 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-107 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-107 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-107 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-107 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-209 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-209 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |
| 76045-209 | Ketorolac Tromethamine | Ketorolac Tromethamine | Fresenius Kabi USA, LLC | ANDA | Current |