MUPIROCIN CALCIUM | N050746 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Prinston Pharmaceutical Inc. FDA-2018-P-0829 Prinston Pharmaceutical Inc. filed this citizen petition pursuant to 21 C.F.R. §§ 10.25(a) and 10.30 requesting that the FDA designate ANDA 201587 held by Glenmark Pharmaceuticals Inc USA as a Reference Standard for Mupirocin Calcium Cream, EQ 2% Base, to replace the current reference standard NDA 0 | 505(q) | 2018-02-22 | Granted | Prinston Pharmaceutical Inc. |
Citizen Petition from Glasshouse Pharmaceuticals Limited Canada FDA-2017-P-3484 Glasshouse Pharmaceuticals Limited Canada filed this petition on June 2, 2017, requesting that the FDA designate Mupirocin Calcium Cream 2% manufactured by Glenmark Generics Inc. U.S.A. and approved under ANDA A201587 as the Reference Standard for mupirocin calcium cream 2%, replacing Bactroban Crea | Other | 2017-06-06 | Denied | Glasshouse Pharmaceuticals Limited Canada |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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