Application 019814
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETAGAN | LEVOBUNOLOL HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.25% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60758-063 | LEVOBUNOLOL HYDROCHLORIDE | levobunolol hydrochloride | Pacific Pharma, Inc. | NDA AUTHORIZED GENERIC | Current |