Application 212719
- Type
- ANDA
- Sponsor
- UNICHEM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 002 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
| 003 | LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-252 | Labetalol Hydrochloride | Labetalol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-253 | Labetalol Hydrochloride | Labetalol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-254 | Labetalol Hydrochloride | Labetalol Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |