DIGOXIN | N020405 | ADVANZ PHARMA (US) CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Concordia Pharmaceuticals (Buchanan Ingersoll and Roone... FDA-2015-P-4566 Concordia Pharmaceuticals filed this citizen petition on December 1, 2015, requesting that FDA amend the May 2008 digoxin tablets bioequivalence guidance to reflect digoxin's narrow therapeutic index status by adopting stricter bioequivalence criteria including 4-way replicated crossover studies and | 505(q) | 2015-12-03 | Denied | Concordia Pharmaceuticals (Buchanan Ingersoll and Rooney PC) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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