BENAZEPRIL HYDROCHLORIDE | N019851 | VALIDUS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-3571 · 9 docket documents 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). | Suitability | 2024-11-13 | Granted | Premier Consulting |
Suitability Petition from Premier Consulting FDA-2024-P-4955 · 9 docket documents 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 | Suitability | 2024-10-24 | Denied | Premier Consulting |
Citizen Petition from Aurobindo Pharma USA, Inc. FDA-2022-P-1785 · 5 docket documents 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Lotensin (benazepril hydrochloride, USP) 5 mg tablets, NDA 019851, held by Validus Pharmaceuticals LLC, was voluntarily withdrawn from sa | 505(q) | 2022-08-04 | Granted | Aurobindo Pharma USA, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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