IRBESARTAN | A077159 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Pharmaceutical, Inc. - Citizen Petition FDA-2012-P-0279 · 3 docket documents Lupin Pharmaceuticals, Inc. filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA formally determine that Teva Pharmaceuticals has forfeited its 180-day marketing exclusivity for generic versions of Avapro brand irbesartan tablets in 75 mg, 150 | 505(q) | 2012-04-03 | Denied | — |
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.
No patent or exclusivity listings for this strength.