Application 075386
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.5% BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-705 | Betaxolol | Betaxolol Hydrochloride | Akorn | ANDA | Current |
| 17478-705 | Betaxolol | Betaxolol Hydrochloride | Akorn | ANDA | Current |
| 17478-705 | Betaxolol | Betaxolol Hydrochloride | Akorn, Inc. | ANDA | Current |
| 17478-705 | Betaxolol | Betaxolol Hydrochloride | Akorn, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8642 | ORIG | 2000-06-30 |