APPLICATION
NDA019141
TYPE
NDA
ORIGINAL APPROVAL
1984-09-04
LATEST ACTION
1996-06-07
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
BETAMETHASONE DIPROPIONATE · ReferencePrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE · OINTMENT · TOPICAL
Approval history
1996-06-07Manufacturing (CMC) · Supplement 12AP
1996-03-07Manufacturing (CMC) · Supplement 14AP
1995-08-17Labeling · Supplement 13AP
1992-07-16Manufacturing (CMC) · Supplement 11AP
1988-11-01Manufacturing (CMC) · Supplement 9AP
1988-11-01Manufacturing (CMC) · Supplement 8AP
1988-11-01Manufacturing (CMC) · Supplement 10AP
1987-10-20Manufacturing (CMC) · Supplement 5AP
1987-07-06Manufacturing (CMC) · Supplement 6AP
1987-04-23Manufacturing (CMC) · Supplement 7AP
1986-06-27Manufacturing (CMC) · Supplement 2AP
1986-03-28Manufacturing (CMC) · Supplement 1AP
1984-09-04OriginalAP
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.