Application 076186
- Type
- ANDA
- Sponsor
- UPSHER SMITH LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0832-0111 | Amantadine Hydrochloride | amantadine hydrochloride | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 0832-0111 | Amantadine Hydrochloride | amantadine hydrochloride | Upsher-Smith Laboratories, LLC | ANDA | Current |
| 70518-3381 | Amantadine Hydrochloride | amantadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |