Application 083639
- Type
- ANDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 75MG | No | No |
| 005 | ENDEP | AMITRIPTYLINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |