APPLICATION
NDA018642
TYPE
NDA
ORIGINAL APPROVAL
1983-03-24
LATEST ACTION
2016-11-22
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
BETA-VALPrescription
BETAMETHASONE VALERATE EQ 0.1% BASE · CREAM · TOPICAL
Approval history
2016-11-22Manufacturing (CMC) · Supplement 25 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 22AP
2000-07-07Manufacturing (CMC) · Supplement 21AP
2000-01-12Manufacturing (CMC) · Supplement 20AP
1996-06-13Manufacturing (CMC) · Supplement 19AP
1995-07-14Manufacturing (CMC) · Supplement 18AP
1995-05-04Manufacturing (CMC) · Supplement 16AP
1995-05-04Manufacturing (CMC) · Supplement 17AP
1994-12-09Manufacturing (CMC) · Supplement 14AP
1994-12-09Manufacturing (CMC) · Supplement 15AP
1994-12-09Manufacturing (CMC) · Supplement 13AP
1993-08-31Manufacturing (CMC) · Supplement 12AP
1993-08-31Manufacturing (CMC) · Supplement 11AP
1993-04-01Manufacturing (CMC) · Supplement 10AP
1992-10-30Manufacturing (CMC) · Supplement 9AP
1992-10-30Manufacturing (CMC) · Supplement 8AP
1989-07-21Manufacturing (CMC) · Supplement 5AP
1988-07-15Labeling · Supplement 4AP
1987-09-10Manufacturing (CMC) · Supplement 3AP
1983-03-24OriginalAP
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.