LOTENSIN

FDA-2024-P-4955

Premier Consulting filed an amendment to its October 23, 2024 ANDA suitability petition (FDA-2024-P-4955) for Benazepril Hydrochloride Oral Liquid, clarifying in response to an FDA information request that the proposed dosage form is a liquid rather than a solution, suspension, or powder for suspens

FDA-2024-P-3571

Premier Consulting filed this petition seeking permission to file an ANDA for Amoxicillin and Benazepril Hydrochloride Oral Liquid, and requesting that the FDA determine that "liquid" is an acceptable dosage form for these drugs under 21 CFR 314.94(a)(5).

FDA-2024-P-4955

Premier Consulting filed an amendment to its ANDA suitability petition (FDA-2024-P-4955) for Benazepril Hydrochloride Oral Liquid, clarifying that the proposed dosage form will be a liquid formulation—either a solution, suspension, or powder for suspension—intended for oral administration, in respon

FDA-2024-P-4955

Premier Consulting filed this ANDA Suitability Petition on October 23, 2024, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA confirm that Benazepril Hydrochloride Oral Liquid (20 mg per 5 mL) is suitable for submission as an Abbreviated New Drug

FDA-2022-P-1785

Aurobindo Pharma USA, Inc., filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether Lotensin (benazepril hydrochloride, USP) 5 mg tablets, NDA 019851, held by Validus Pharmaceuticals LLC, was voluntarily withdrawn from sa