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 | Open | Premier Research International |
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 | Open | Premier Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.
Sandoz's Lotrel (amlodipine besylate/benazepril hydrochloride) NDA 020364 supplement 003 had its therapeutic equivalence code changed from AB.
Old: AB
Sandoz's Lotrel (amlodipine besylate; benazepril hydrochloride) was discontinued, changing from prescription to discontinued status in FDA records.
Old: RX
New: DISCN
Sandoz's Lotrel (amlodipine besylate; benazepril hydrochloride) NDA 020364 supplement 002 had its therapeutic equivalence code changed from AB to a different rating.
Old: AB
Sandoz's Lotrel (amlodipine besylate; benazepril hydrochloride) NDA 020364 was discontinued, changing from prescription to discontinued status.
Old: RX
New: DISCN
Sandoz's Lotrel (amlodipine besylate; benazepril hydrochloride) NDA 020364 supplement 004 therapeutic equivalence code changed from AB.
Old: AB
Sandoz's Lotrel (amlodipine besylate; benazepril hydrochloride) NDA 020364 supplement 005 had its therapeutic equivalence code changed from AB.
Old: AB
Sandoz's Lotrel (amlodipine besylate/benazepril hydrochloride) NDA 020364 supplement 007 therapeutic equivalence rating changed from AB to a different code.
Old: AB
Sandoz discontinued Lotrel (amlodipine besylate; benazepril hydrochloride) NDA 020364, changing its status from prescription to discontinued.
Old: RX
New: DISCN
Sandoz's Lotrel (amlodipine besylate/benazepril hydrochloride) NDA 020364 supplement 006 is no longer designated as a Reference Standard product.
Old: Yes
New: No
Sandoz's Lotrel (amlodipine besylate/benazepril hydrochloride) NDA 020364 supplement 006 had its therapeutic equivalence code changed from AB to a different rating.
Old: AB
Sandoz's Lotrel (amlodipine besylate/benazepril hydrochloride) NDA 020364 transitioned from prescription (RX) to discontinued (DISCN) status.
Old: RX
New: DISCN
Sandoz's LOTREL (amlodipine besylate/benazepril hydrochloride) NDA 020364 was discontinued, changing from prescription to discontinued status.
Old: RX
New: DISCN
Sandoz's LOTREL (amlodipine besylate; benazepril hydrochloride) NDA 020364 was discontinued, changing product type from prescription to discontinued status.
Old: RX
New: DISCN