Application 075642
- Type
- ANDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 5MG;6.25MG | No | No |
| 002 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 2.5MG;6.25MG | No | No |
| 003 | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | TABLET;ORAL | 10MG;6.25MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30971 | ORIG | 2000-12-27 |