Application 022427
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACUVAIL | KETOROLAC TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | 0.45% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-3507 | ACUVAIL | ketorolac tromethamine | Allergan, Inc. | NDA | Current |
| 0023-3507 | ACUVAIL | ketorolac tromethamine | Allergan, Inc. | NDA | Current |
| 0023-3507 | ACUVAIL | ketorolac tromethamine | Allergan, Inc. | NDA | Current |
| 0023-3507 | ACUVAIL | ketorolac tromethamine | Allergan, Inc. | NDA | Current |
| 0023-3507 | ACUVAIL | ketorolac tromethamine | Allergan, Inc. | NDA | Current |
| 0023-3507 | ACUVAIL | ketorolac tromethamine | Allergan, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78558 | SUPPL | 2024-08-05 |
| 78562 | SUPPL | 2024-05-28 |
| 17581 | SUPPL | 2014-12-10 |
| 7382 | SUPPL | 2014-12-05 |
| 38701 | SUPPL | 2012-11-19 |
| 7381 | SUPPL | 2012-11-19 |
| 29723 | SUPPL | 2012-11-16 |
| 17580 | SUPPL | 2012-11-16 |
| 29722 | SUPPL | 2010-07-01 |
| 24304 | ORIG | 2010-01-21 |
| 22019 | ORIG | 2010-01-21 |
| 17579 | ORIG | 2009-08-14 |
| 7380 | ORIG | 2009-07-30 |