Application 090048
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8100 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8100 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8100 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8192 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8192 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8192 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8319 | Memantine | Memantine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6505 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6505 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6505 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6505 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6506 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6506 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6506 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 0904-6506 | Memantine | Memantine | Major Pharmaceuticals | ANDA | Current |
| 55111-596 | Memantine | Memantine | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-597 | Memantine | Memantine | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55154-4151 | Memantine | Memantine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7637 | Memantine | Memantine | Cardinal Health | ANDA | Current |
| 55154-7637 | Memantine | Memantine | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7637 | Memantine | Memantine | Cardinal Health | ANDA | Current |
| 55154-7637 | Memantine | Memantine | Cardinal Health | ANDA | Current |
| 60687-173 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-173 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-173 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-173 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-184 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-184 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-184 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 60687-184 | Memantine | Memantine | American Health Packaging | ANDA | Current |
| 70518-3297 | Memantine | Memantine | REMEDYREPACK INC. | ANDA | Current |
| 72603-118 | Memantine | Memantine | NorthStar RxLLC | ANDA | Current |
| 72603-119 | Memantine | Memantine | NorthStar RxLLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31446 | ORIG | 2010-04-19 |