← FDA DRUG APPROVALS

FDA NDA · NDA218528

SCOMARA

Sponsor: AFT PHARMACEUTICALS LTD

APPLICATION
NDA218528
TYPE
NDA
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

SCOMARAPrescription
SIROLIMUS 0.5% sirolimus in 30g tube · CREAM · TOPICAL

Approval history

2026-07-20Type 3 - New Dosage Form · Original · standardLetterTA
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 →