Application 022525
- Type
- NDA
- Sponsor
- FOREST LABS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 7MG | Yes | No |
| 002 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 14MG | Yes | No |
| 003 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 21MG | Yes | No |
| 004 | NAMENDA XR | MEMANTINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 28MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0456-3400 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3400 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3407 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3407 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3407 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3407 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3414 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3414 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3414 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3414 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3421 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3421 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3421 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3421 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3428 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3428 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3428 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 0456-3428 | Namenda | memantine hydrochloride | Allergan, Inc. | NDA | Current |
| 60505-6208 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6208 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6208 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6209 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6209 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6209 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6210 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6210 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6210 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6211 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6211 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 60505-6211 | Memantine Hydrochloride | memantine hydrochloride | Apotex Corp | NDA | Current |
| 68151-5755 | Namenda | memantine hydrochloride | Carilion Materials Management | NDA | Current |
| 68151-5817 | Namenda | memantine hydrochloride | Carilion Materials Management | NDA | Current |
| 68151-5829 | Namenda XR | memantine hydrochloride | Carilion Materials Management | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61095 | SUPPL | 2019-11-29 |
| 61053 | SUPPL | 2019-11-26 |
| 7499 | SUPPL | 2014-10-01 |
| 38812 | SUPPL | 2014-09-30 |
| 38811 | SUPPL | 2014-07-09 |
| 29830 | SUPPL | 2014-07-07 |
| 24332 | ORIG | 2010-12-23 |
| 22045 | ORIG | 2010-12-23 |
| 29829 | ORIG | 2010-06-24 |
| 17680 | ORIG | 2010-06-02 |
| 58108 | ORIG | 1900-01-01 |
| 51327 | ORIG | 1900-01-01 |
| 51326 | ORIG | 1900-01-01 |
| 51325 | ORIG | 1900-01-01 |