Application 206032
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5435 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5435 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5436 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5436 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5437 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5437 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5438 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5438 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5438 | Memantine Hydrochloride | memantine | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45446 | ORIG | 2016-10-03 |