Application 206066
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BEPOTASTINE BESILATE | BEPOTASTINE BESILATE | SOLUTION/DROPS;OPHTHALMIC | 1.5% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-6111 | Bepotastine Besilate | Bepotastine Besilate | Apotex Corp. | ANDA | Current |
| 60505-6111 | Bepotastine Besilate | Bepotastine Besilate | Apotex Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58401 | ORIG | 2019-04-24 |