Application 214897
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMANTADINE | AMANTADINE | CAPSULE, EXTENDED RELEASE;ORAL | 65.5MG | No | No |
| 002 | AMANTADINE | AMANTADINE | CAPSULE, EXTENDED RELEASE;ORAL | 137MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72739 | ORIG | 2022-11-28 |