Application 210587
- Type
- ANDA
- Sponsor
- POLYGEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52605-071 | memantine hydrochloride | memantine hydrochloride | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-071 | memantine hydrochloride | memantine hydrochloride | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-072 | Memantine hydrochloride | Memantine hydrochloride | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |
| 52605-072 | Memantine hydrochloride | Memantine hydrochloride | POLYGEN PHARMACEUTICALS INC. | ANDA | Current |