KETOCONAZOLE | A075638 | SUN PHARMA CANADA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teligent Pharma, Inc. FDA-2017-P-3468 Teligent Pharma, Inc. filed a citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate either Ketoconazole Cream 2% ANDA 076294 held by Fougera Pharmaceuticals, Inc. or KETOZOLE Cream 2% ANDA 075638 held by Taro Pharmaceuticals USA, Inc. as | 505(q) | 2017-06-02 | Denied | Teligent Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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