Application 021127
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OPTIVAR | AZELASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83404 | SUPPL | 2025-09-19 |
| 83391 | SUPPL | 2025-09-19 |
| 14445 | SUPPL | 2008-07-09 |
| 4393 | SUPPL | 2008-07-08 |
| 4391 | SUPPL | 2004-09-03 |
| 36164 | SUPPL | 2004-05-04 |
| 26834 | SUPPL | 2004-05-04 |
| 14444 | SUPPL | 2004-05-04 |
| 4392 | SUPPL | 2004-05-04 |
| 41966 | ORIG | 2002-05-22 |
| 14443 | ORIG | 2000-05-22 |
| 4390 | ORIG | 2000-05-22 |