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(benazepril hydrochloride, USP) 5 mg tablets, NDA 019851, held by Validus Pharmaceuticals LLC, was voluntarily withdrawn from sa | 505(q) | 2022-08-04 | Granted | Aurobindo Pharma USA |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