AMLODIPINE BESYLATE; VALSARTAN | N021990 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pfizer Inc FDA-2007-P-0350 Pfizer Inc submitted this citizen petition on March 21, 2007, requesting that the FDA rescind final approval of Novartis's NDA 20-364 for Lotrel (amlodipine besylate and benazepril hydrochloride) and withhold approval of any supplemental NDAs, arguing that the Lotrel NDA should be reclassified as a | 505(q) | 2008-05-23 | Denied | Pfizer Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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