HYDROCHLOROTHIAZIDE; IRBESARTAN | N020758 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0822 Lupin Pharmaceuticals, Inc. filed this citizen petition on November 10, 2011, requesting that the FDA determine whether Sanofi Aventis voluntarily discontinued AVALIDE (Irbesartan-Hydrochlorothiazide) Tablets, 300 mg/25 mg (NDA 020758) for reasons unrelated to safety or efficacy, and if so, to allow | 505(q) | 2011-11-21 | Granted | — |
Aurobindo Pharmaceuticals Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2011-P-0743 Aurobindo Pharmaceuticals Limited, through EAS Consulting Group LLC, filed this citizen petition on October 11, 2011, requesting that the FDA determine whether Avalide (irbesartan and hydrochlorothiazide) Tablets in the 300 and 25 mg strength, approved under NDA 20-758 and manufactured by Sanofi Ave | 505(q) | 2011-10-21 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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