CUTIVATE

FDA-2020-P-2146 · 3 docket documents

BF Innovation Inc., acting on behalf of Bright Future Pharmaceutical Laboratories Limited, filed this citizen petition requesting FDA confirmation that CUTIVATE (Fluticasone Propionate Ointment 0.005%), the Reference Listed Drug approved under NDA N019957 and held by Fougera Pharmaceuticals Inc., wa

FDA-2018-P-3746 · 5 docket documents

BF Innovation Inc., on behalf of Bright Future Pharmaceutical Laboratories Limited, submitted a citizen petition requesting that the FDA designate Fluticasone Propionate Ointment 0.005% (Application No. A076668) by Perrigo New York Inc. as an additional Reference Standard under Section 505(j) of the

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

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

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