Application 212407
- Type
- ANDA
- Sponsor
- EDENBRIDGE PHARMS
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 |
|---|---|---|---|---|---|
| 42799-118 | Amantadine Hydrochloride | Amantadine Hydrochloride | Edenbridge Pharmaceuticals LLC. | ANDA | Current |