← FDA DRUG APPROVALS
FDA ANDA · ANDA076002
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Sponsor: ACTAVIS MID ATLANTIC
APPLICATION
ANDA076002
TYPE
ANDA
ORIGINAL APPROVAL
2002-08-02
LATEST ACTION
2020-07-06
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATEPrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE, CLOTRIMAZOLE 1% · CREAM · TOPICAL
Approval history
2020-07-06Labeling · Supplement 21 · standardAP
2017-01-23Labeling · Supplement 17 · standardAP
2008-05-13Labeling · Supplement 7AP
2004-10-20Labeling · Supplement 4AP
2002-08-02OriginalAP
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.