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Application 078145
- Type
- ANDA
- Sponsor
- LUITPOLD
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 |
|---|
| 0517-0601 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | American Regent, Inc. | ANDA | Current |
| 0517-0801 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | American Regent, Inc. | ANDA | Current |
| 0517-0902 | Ketorolac Tromethamine | KETOROLAC TROMETHAMINE | American Regent, Inc. | ANDA | Current |