Application 210092
- Type
- ANDA
- Sponsor
- GLAND PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68083-287 | Azelastine Hydrochloride | Azelastine Hydrochloride | Gland Pharma Limited | ANDA | Current |
| 68083-287 | Azelastine Hydrochloride | Azelastine Hydrochloride | Gland Pharma Limited | ANDA | Current |
| 72266-141 | Azelastine Hydrochloride | Azelastine Hydrochloride | Fosun Pharma USA Inc | ANDA | Current |