Application 090017
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | 0.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-219 | Ketorolac Tromethamine | Ketorolac Tromethamine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-220 | Ketorolac Tromethamine | Ketorolac Tromethamine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-221 | Ketorolac Tromethamine | Ketorolac Tromethamine | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31440 | ORIG | 2009-11-23 |