← FDA DRUG APPROVALS

FDA ANDA · ANDA076633

FLUTICASONE PROPIONATE

Sponsor: ENCUBE

APPLICATION
ANDA076633
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-14
LATEST ACTION
2012-11-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

FLUTICASONE PROPIONATEPrescription
FLUTICASONE PROPIONATE 0.05% · CREAM · TOPICAL

Approval history

2012-11-30Labeling · Supplement 16 · standardAP
2011-02-24Labeling · Supplement 12AP
2004-05-14OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →