APPLICATION
ANDA090633
TYPE
ANDA
ORIGINAL APPROVAL
2010-03-24
LATEST ACTION
2019-05-24
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
CALCIPOTRIENEPrescription
CALCIPOTRIENE 0.005% · OINTMENT · TOPICAL
Approval history
2019-05-24Labeling · Supplement 5 · standardAP
2019-05-24Labeling · Supplement 6 · standardAP
2015-08-13Manufacturing (CMC) · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.