FLUTICASONE PROPIONATE | N019958 | FOUGERA PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sandoz Inc FDA-2016-P-3356 Sandoz Inc. filed this citizen petition under 21 C.F.R. §§ 10.25, 10.30 and Sections 505(j) and 505(q) of the FDCA requesting that the FDA refrain from approving any ANDA referencing Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) as the reference listed | 505(q) | 2016-10-17 | Denied | Sandoz Inc |
Nycomed US, Inc. - Citizen Petition FDA-2010-P-0570 Nycomed US, Inc. filed this citizen petition on October 29, 2010, requesting that FDA refrain from approving any ANDA for Cutivate (fluticasone propionate) Lotion or other topical corticosteroids indicated for pediatric use unless the application includes bioequivalence study results from pediatric | 505(q) | 2010-11-10 | Denied | — |
GlaxoSmithKline (Ropes & Gray LLP) - Citizen Petition FDA-2009-P-0597 GlaxoSmithKline filed this citizen petition on December 16, 2009, requesting that the FDA ensure that abbreviated new drug applications (ANDAs) for generic versions of inhalation products containing fluticasone propionate and/or salmeterol xinafoate not be approved unless the generic copies maintain | 505(q) | 2009-12-29 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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