APPLICATION
NDA018741
TYPE
NDA
ORIGINAL APPROVAL
1983-07-27
LATEST ACTION
2019-05-01
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT, AUGMENTED
MARKETING STATUS
Prescription
Products
DIPROLENE · ReferencePrescription
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE · OINTMENT, AUGMENTED · TOPICAL
Approval history
1998-11-10Manufacturing (CMC) · Supplement 21 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 19 · standardAP
1998-06-15Manufacturing (CMC) · Supplement 20 · standardAP
1998-06-15Manufacturing (CMC) · Supplement 18 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 17 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 15 · standardAP
1990-08-01Manufacturing (CMC) · Supplement 14 · standardAP
1989-05-24Labeling · Supplement 13AP
1988-11-30Manufacturing (CMC) · Supplement 12 · standardAP
1987-10-29Manufacturing (CMC) · Supplement 9 · standardAP
1986-09-29Labeling · Supplement 1AP
1986-09-12Manufacturing (CMC) · Supplement 8 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 7 · standardAP
1986-04-23Manufacturing (CMC) · Supplement 5 · standardAP
1985-02-22Manufacturing (CMC) · Supplement 4 · standardAP
1984-11-16Labeling · Supplement 3AP
1983-12-15Labeling · Supplement 2AP
1983-07-27Type 3 - New Dosage Form · Original · 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.
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