Application 090051
- Type
- ANDA
- Sponsor
- LUPIN LTD
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 |
|---|---|---|---|---|---|
| 68180-229 | Memantine hydrochloride | Memantine hydrochloride | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-229 | Memantine hydrochloride | Memantine hydrochloride | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-230 | Memantine hydrochloride | Memantine hydrochloride | Lupin Pharmaceuticals, Inc. | ANDA | Current |
| 68180-230 | Memantine hydrochloride | Memantine hydrochloride | Lupin Pharmaceuticals, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31447 | ORIG | 2016-02-18 |