Application 075223
- Type
- ANDA
- Sponsor
- APOTHECON
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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30801 | ORIG | 1998-11-23 |