Application 090870
- Type
- ANDA
- Sponsor
- BRECKENRIDGE
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 |
|---|---|---|---|---|---|
| 50090-1635 | Epinastine Hydrochloride | Epinastine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51991-836 | Epinastine Hydrochloride | Epinastine Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-836 | Epinastine Hydrochloride | Epinastine Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-836 | Epinastine Hydrochloride | Epinastine Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
| 51991-836 | Epinastine Hydrochloride | Epinastine Hydrochloride | Breckenridge Pharmaceutical, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9302 | ORIG | 2011-11-21 |