Application 090919
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0584 | Epinastine Hydrochloride | Epinastine Hydrochloride | Apotex Corp. | ANDA | Current |
| 60505-0584 | Epinastine Hydrochloride | Epinastine Hydrochloride | Apotex Corp. | ANDA | Current |