MEMANTINE HYDROCHLORIDE | N021627 | ALLERGAN SALES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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requesting that the FDA determine the discontinued formulation of Namenda (Memantine HCl) Tablets 5mg and 10mg was not withdrawn for safety or efficacy reasons, so that Strides' ANDA ref | 505(q) | 2014-09-29 | Withdrawn | Strides Arcolab Limited, India |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hydrochloride) Tablets in 15 mg and 20 mg strengths, approved under NDA 21-487 by Forest Laboratories, were voluntarily withdrawn from sale fo | 505(q) | 2008-06-26 | Denied | — |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.
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