AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | N020364 | SANDOZ INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
NOVARTIS PHARMACEUTICALS CORPORATION v. APOTEX INC. et al 1 patentANDA 91431amlodipine and benazepril hydrochloride | D.N.J. | 2012-09-06 | Terminated 2013-10-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Premier Research International, LLC FDA-2025-P-7283 Premier Research International, LLC filed this ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an ANDA for Amlodipine and Benazepril hydrochloride Powder for Oral Suspension, which differs in dosage form from the refe | Suitability | 2025-12-22 | Denied | Premier Research International, LLC |
Suitability Petition from Premier Consulting FDA-2024-P-3571 Premier Consulting filed this ANDA suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA confirmation that amlodipine and benazepril hydrochloride oral liquid is suitable for submission as an abbreviated new drug application, differing in dosage f | Suitability | 2024-07-30 | Granted | Premier Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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