Application 214651
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 7MG | No | No |
| 002 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 14MG | No | No |
| 003 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 21MG | No | No |
| 004 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 28MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-404 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-404 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-405 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-405 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-406 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-406 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-407 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-407 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-408 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-408 | MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | ANDA | Current |