FLUTICASONE PROPIONATE | N020121 | HALEON US HOLDINGS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sandoz Inc FDA-2016-P-3356 · 18 docket documents 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 |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2016-P-1725 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether GSK's Flonase (fluticasone propionate) Nasal Spray, 0.05 mg (Rx), approved under NDA 020121, has been voluntarily withdrawn for safety or effectiveness reasons, and if not, to design | 505(q) | 2016-06-23 | Granted | Lachman Consultant Services, Inc. |
Nycomed US, Inc. - Citizen Petition FDA-2010-P-0570 · 5 docket documents 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 · 35 docket documents 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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