VENLAFAXINE HYDROCHLORIDE | N020151 | WYETH PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-4954 Premier Consulting filed an amendment to its suitability petition seeking permission to file an ANDA for venlafaxine hydrochloride and venlafaxine hydrochloride oral liquid dosage form. The petitioner requests that the FDA complete review of the petition and determine that the proposed drug product | Suitability | 2024-11-13 | Granted | Premier Consulting |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2003-P-0351 Lachman Consultant Services, Inc. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Venlafaxine Hydrochloride Extended-Release Tablets in 37.5 mg, 75 mg, and 150 mg strengths suitable for submission as an ANDA, with Eff | Other | 2008-08-13 | Granted | — |
Sun Pharmaceutical Industries, Ltd. - Citizen Petition FDA-2008-P-0247 Sun Pharmaceutical Industries, Ltd., through its United States agent Kendle Regulatory Affairs, filed this petition under section 505(j)(2)(C) requesting a determination that an Abbreviated New Drug Application may be submitted for Venlafaxine Hydrochloride Extended Release Oral Tablets at 225 mg an | Other | 2008-04-22 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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