Application 019174
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;100MG | No | No |
| 002 | TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;200MG | No | No |
| 003 | TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;300MG | No | No |
| 004 | TRANDATE HCT | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | TABLET;ORAL | 25MG;400MG | No | No |