PAZOPANIB HYDROCHLORIDE | N022465 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman Phelps McNamara PC FDA-2021-P-0271 · 4 docket documents Hyman, Phelps & McNamara PC filed this petition requesting that the FDA determine whether VOTRIENT (pazopanib hydrochloride) Tablets, 400 mg, approved under NDA 022465 and held by Novartis Pharmaceuticals Corporation, was voluntarily withdrawn for safety or effectiveness reasons pursuant to Sections | Other | 2021-03-05 | Granted | Hyman Phelps McNamara PC |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-2362 · 6 docket documents Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Pazopanib Tablets 800 mg suitable for submission as an abbreviated new drug application, with VOTRIENT (pazopanib) Tablets 200 mg | Other | 2018-06-19 | Withdrawn | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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