BENAZEPRIL HYDROCHLORIDE | A076211 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting 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 | Suitability | 2024-12-02 | Denied | Premier Consulting |
Amendment to Suitability Petition from Premier Consulting 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). | Suitability | 2024-11-13 | Granted | Premier Consulting |
Amendment to Suitability Petition from Premier Consulting 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 | Suitability | 2024-11-13 | Denied | Premier Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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