MEMANTINE HYDROCHLORIDE | N021487 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sean Mahoney Upsher-Smith Laboratories Inc FDA-2014-P-1483 · 3 docket documents Upsher-Smith Laboratories, Inc. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 requesting that the FDA formally determine that Namenda (memantine hydrochloride) tablets in 5 mg and 10 mg streng | 505(q) | 2014-10-01 | Withdrawn | Sean Mahoney Upsher-Smith Laboratories Inc |
Citizen Petition from Strides Arcolab Limited, India FDA-2014-P-1472 · 3 docket documents Strides Arcolab Limited filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine the discontinued formulation of Namenda (Memantine HCl) Tablets 5mg and 10mg was not withdrawn for safety or efficacy reasons, so that Strides' ANDA ref | 505(q) | 2014-09-29 | Withdrawn | Strides Arcolab Limited, India |
Citizen Petition From Apotex Corp. FDA-2014-P-0099 · 3 docket documents Apotex Corp. filed a citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to receive any abbreviated new drug applications for memantine hydrochloride extended release capsules unless the bioequivalence studies are conducted using a crossover | 505(q) | 2014-01-31 | Denied | Apotex Corp. |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0191 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether Namenda (memantine hydrochloride) Tablets in 15 mg and 20 mg strengths, approved under NDA 21-487 by Forest Laboratories, were voluntarily withdrawn from sale fo | 505(q) | 2008-06-26 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.3724
per ea
Lowest NADAC/Unit
$0.0645
per ea
Brand NDCs
0
Generic NDCs
5
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00591390087MEMANTINE 5-10 MG TITRATION PK | $0.3724 | EA | Generic | — | 2025-10-22 |
| 00591387044MEMANTINE HCL 5 MG TABLET | $0.0800 | EA | Generic | — | 2026-06-17 |
| 00591387060MEMANTINE HCL 5 MG TABLET | $0.0800 | EA | Generic | — | 2026-06-17 |
| 00591387544MEMANTINE HCL 10 MG TABLET | $0.0645 | EA | Generic | — | 2026-06-17 |
| 00591387560MEMANTINE HCL 10 MG TABLET | $0.0645 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.