BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | N020033 | VALIDUS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research International, LLC FDA-2025-P-7284 Premier Research International, LLC filed this ANDA Suitability Petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93, requesting FDA confirmation that Benazepril Hydrochloride and Hydrochlorothiazide Powder for Oral Suspension is suitable for ANDA s | Suitability | 2025-12-22 | Open | Premier Research International |
Suitability Petition from Premier Consulting FDA-2024-P-4954 Premier Consulting filed this ANDA suitability petition in October 2024 requesting FDA confirmation that benazepril hydrochloride and hydrochlorothiazide oral liquid is suitable for submission as an abbreviated new drug application under section 505(j)(2)(C). The petitioner also seeks a full waiver | Suitability | 2024-10-24 | Open | Premier Consulting |
Citizen Petition from EAS Consulting Group ( Jubilant Generics Ltd.) FDA-2017-P-4852 Jubilant Generics Ltd., through EAS Consulting Group, filed this petition pursuant to 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine the discontinuation of the 5 mg/6.25 mg strength of LOTENSIN HCT (Benazepril Hydrochloride and Hydrochlorothiazide, NDA N02003 | Other | 2017-08-11 | Open | EAS Consulting Group ( Jubilant Generics Ltd.) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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