Application 214378
- Type
- ANDA
- Sponsor
- HUMANWELL PURACAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAPENTADOL HYDROCHLORIDE | TAPENTADOL HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 002 | TAPENTADOL HYDROCHLORIDE | TAPENTADOL HYDROCHLORIDE | TABLET; ORAL | EQ 75MG BASE || EQ 100MG BASE | No | No |
| 003 | TAPENTADOL HYDROCHLORIDE | TAPENTADOL HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84985 | ORIG | 2026-02-11 |