Application 019700
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ACULAR | KETOROLAC TROMETHAMINE | SOLUTION/DROPS;OPHTHALMIC | 0.5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-2181 | Acular | Ketorolac Tromethamine | Allergan, Inc. | NDA | Current |
| 0023-2181 | Acular | Ketorolac Tromethamine | Allergan, Inc. | NDA | Current |
| 0023-2181 | Acular | Ketorolac Tromethamine | Allergan, Inc. | NDA | Current |
| 21695-463 | ACULAR | KETOROLAC TROMETHAMINE | Rebel Distributors Corp. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83402 | SUPPL | 2025-09-19 |
| 83389 | SUPPL | 2025-09-19 |
| 11641 | SUPPL | 2012-06-18 |
| 1517 | SUPPL | 2012-06-18 |
| 20299 | SUPPL | 2009-01-12 |
| 33877 | SUPPL | 2005-03-11 |
| 19108 | SUPPL | 2005-03-11 |
| 11640 | SUPPL | 2005-03-11 |
| 1516 | SUPPL | 2005-03-11 |
| 11639 | SUPPL | 2003-06-16 |
| 33876 | SUPPL | 2002-02-08 |
| 19107 | SUPPL | 2002-02-08 |