Application 210403
- Type
- ANDA
- Sponsor
- JUBILANT GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59746-699 | amantadine hydrochloride | Amantadine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-699 | amantadine hydrochloride | Amantadine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |