HYDRODIURIL

FDA-2024-P-4956

Premier Consulting filed an amendment to an ANDA suitability petition (FDA-2024-P-4956) for hydrochlorothiazide oral liquid, clarifying in response to an FDA information request that the proposed dosage form is specifically a liquid rather than a solution, suspension, or powder for suspension, and c

FDA-2024-P-4956

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

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

FDA-2006-P-0271

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