HYDROCHLOROTHIAZIDE | N011793 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-4956 · 9 docket documents Premier Consulting filed this amendment to its ANDA suitability petition (FDA-2024-P-4956) for Hydrochlorothiazide Oral Liquid, clarifying that the proposed dosage form will be a liquid administered orally, which the petitioner indicates may be formulated as a solution, suspension, or powder for sus | Suitability | 2024-11-13 | Granted | Premier Consulting |
Aurobindo Pharmaceuticals Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2011-P-0743 · 4 docket documents 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 | — |
CITIZEN PETITION from Caraco Pharmaceutical Laboratories, Ltd. FDA-2006-P-0271 · 6 docket documents Caraco Pharmaceutical Laboratories, Ltd. filed a citizen petition under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the reference listed drug Hydrochlorothiazide Tablets USP 100 mg (ANDA 85-022, held by IVAX Pharmaceuticals Inc.) was vol | Other | 2008-11-17 | Open | Caraco Pharmaceutical Laboratories, Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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