Application 078737
- Type
- ANDA
- Sponsor
- SUN PHARM
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 |
|---|---|---|---|---|---|
| 47335-933 | ketorolac tromethamine | ketorolac tromethamine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-934 | ketorolac tromethamine | ketorolac tromethamine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-935 | ketorolac tromethamine | ketorolac tromethamine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |