APPLICATION
ANDA090898
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-16
LATEST ACTION
2019-09-06
ROUTE
TOPICAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Discontinued
Products
CLOBETASOL PROPIONATEDiscontinued
CLOBETASOL PROPIONATE 0.05% · SPRAY · TOPICAL
Approval history
2019-09-06Labeling · Supplement 6 · standardAP
2019-09-06Labeling · Supplement 4 · standardAP
2017-11-17Manufacturing (CMC) · Supplement 3 · unknownAP
2017-11-17Labeling · Supplement 1 · standardAP
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.