Application 213830
- Type
- ANDA
- Sponsor
- UNICHEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 2.5MG BASE | No | No |
| 002 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 003 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 004 | NEBIVOLOL HYDROCHLORIDE | NEBIVOLOL HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-375 | Nebivolol Hydrochloride | Nebivolol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-376 | Nebivolol Hydrochloride | Nebivolol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-377 | Nebivolol Hydrochloride | Nebivolol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-378 | Nebivolol Hydrochloride | Nebivolol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |