APPLICATION
ANDA070051
TYPE
ANDA
ORIGINAL APPROVAL
1984-10-10
LATEST ACTION
2001-08-31
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
BETAMETHASONE VALERATEPrescription
BETAMETHASONE VALERATE EQ 0.1% BASE · OINTMENT · TOPICAL
Approval history
2001-08-31Manufacturing (CMC) · Supplement 17AP
2001-05-30Manufacturing (CMC) · Supplement 16AP
2000-12-29Manufacturing (CMC) · Supplement 15AP
1996-09-13Manufacturing (CMC) · Supplement 13AP
1996-09-13Manufacturing (CMC) · Supplement 11AP
1996-09-13Manufacturing (CMC) · Supplement 14AP
1996-09-13Manufacturing (CMC) · Supplement 12AP
1996-06-28Manufacturing (CMC) · Supplement 10AP
1996-06-10Manufacturing (CMC) · Supplement 7AP
1996-06-10Manufacturing (CMC) · Supplement 8AP
1996-02-07Manufacturing (CMC) · Supplement 9AP
1994-04-15Labeling · Supplement 6AP
1993-01-29Manufacturing (CMC) · Supplement 5AP
1992-07-29Labeling · Supplement 3AP
1989-09-11Manufacturing (CMC) · Supplement 4AP
1984-10-10OriginalAP
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.