VENLAFAXINE HYDROCHLORIDE | A091272 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Osmotica Pharmaceutical US LLC FDA-2016-P-4341 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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