HYDROCHLOROTHIAZIDE; IRBESARTAN | N020758 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2011-P-0822 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition on November 10, 2011, requesting that the FDA determine whether Sanofi Aventis voluntarily discontinued AVALIDE (Irbesartan-Hydrochlorothiazide) Tablets, 300 mg/25 mg (NDA 020758) for reasons unrelated to safety or efficacy, and if so, to allow | 505(q) | 2011-11-21 | Granted | — |
Aurobindo Pharmaceuticals Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2011-P-0743 · 4 docket documents Aurobindo Pharmaceuticals Limited, through EAS Consulting Group LLC, filed this citizen petition on October 11, 2011, requesting that the FDA determine whether Avalide (irbesartan and hydrochlorothiazide) Tablets in the 300 and 25 mg strength, approved under NDA 20-758 and manufactured by Sanofi Ave | 505(q) | 2011-10-21 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.91
per ea
Lowest NADAC/Unit
$8.91
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00024585530AVALIDE 150-12.5 MG TABLET | $8.91 | EA | Brand | $0.1676 | 2025-10-22 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.