Application 090951
- Type
- ANDA
- Sponsor
- SOMERSET THERAPS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70069-008 | EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | Somerset Therapeutics, LLC | ANDA | Current |
| 70069-008 | EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | Somerset Therapeutics, LLC | ANDA | Current |
| 70069-008 | EPINASTINE HYDROCHLORIDE | EPINASTINE HYDROCHLORIDE | Somerset Therapeutics, LLC | ANDA | Current |