MEMANTINE HYDROCHLORIDE | N021487 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sean Mahoney Upsher-Smith Laboratories Inc FDA-2014-P-1483 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FDA formally determine that Namenda (memantine hydrochloride) tablets in 5 mg and 10 mg streng | 505(q) | 2014-10-01 | Withdrawn | Sean Mahoney Upsher-Smith Laboratories Inc |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 Apotex Corp. FDA-2014-P-0099 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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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