DIGOXIN | N020405 | ADVANZ PHARMA (US) CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Concordia Pharmaceuticals (Buchanan Ingersoll and Roone... FDA-2015-P-4566 · 5 docket documents 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 | Partially Denied | Concordia Pharmaceuticals (Buchanan Ingersoll and Rooney PC) |
Covis Pharma Sarl (Buchanan Ingersoll & Rooney PC) - Citizen Petition FDA-2013-P-1376 · 4 docket documents Covis Pharma Sarl, through counsel Buchanan Ingersoll & Rooney PC, filed this citizen petition under 21 U.S.C. § 355(j) requesting that FDA confirm that Covis is entitled to three-year marketing exclusivity for the 0.0625 mg and 0.1875 mg dosage strengths of digoxin tablets under NDA 20-405, arguing | 505(q) | 2013-11-27 | Partially Denied | — |
Covis Pharma Sarl (Buchanan Ingersoll & Rooney PC) - Citizen Petition FDA-2013-P-1377 · 4 docket documents Covis Pharma Sarl filed this citizen petition under 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all ANDA sponsors seeking to market generic versions of Lanoxin tablets at 0.0625 mg and 0.1875 mg strengths to conduct and pass the same dissolution and blend unifo | 505(q) | 2013-11-25 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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