VENLAFAXINE HYDROCHLORIDE | A091272 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Osmotica Pharmaceutical US LLC FDA-2016-P-4341 · 7 docket documents Osmotica Pharmaceutical US LLC filed this citizen petition on December 9, 2016, under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require any abbreviated new drug application seeking approval of venlafaxine hydrochloride extended-release tablets at 225 mg that | 505(q) | 2016-12-13 | Denied | Osmotica Pharmaceutical US LLC |
Osmotica Pharmaceutical Corporation - Citizen Petition FDA-2012-P-0515 · 3 docket documents Osmotica Pharmaceutical Corporation filed this citizen petition under Federal Food, Drug, and Cosmetic Act section 505(q) requesting that FDA refuse to approve Sun Pharma Global Inc.'s supplement to ANDA No. 091272 for generic Venlafaxine Hydrochloride Extended-Release Tablets, 225 mg, if the tablet | 505(q) | 2012-05-28 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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