APPLICATION
NDA019555
TYPE
NDA
ORIGINAL APPROVAL
1987-04-27
LATEST ACTION
2019-05-01
ROUTE
TOPICAL
DOSAGE FORM
CREAM, AUGMENTED
MARKETING STATUS
Discontinued
Products
DIPROLENE AF · ReferenceDiscontinued
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM, AUGMENTED · TOPICAL
Approval history
2001-04-04Manufacturing (CMC) · Supplement 17 · standardAP
2000-08-14Manufacturing (CMC) · Supplement 15 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 14 · standardAP
1998-12-07Manufacturing (CMC) · Supplement 12 · standardAP
1998-11-10Manufacturing (CMC) · Supplement 13 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 11 · standardAP
1998-06-15Manufacturing (CMC) · Supplement 10 · standardAP
1995-11-30Manufacturing (CMC) · Supplement 9 · standardAP
1990-08-01Manufacturing (CMC) · Supplement 6 · standardAP
1990-06-29Manufacturing (CMC) · Supplement 7 · standardAP
1989-05-24Labeling · Supplement 5AP
1988-11-08Labeling · Supplement 4AP
1987-10-29Manufacturing (CMC) · Supplement 2 · standardAP
1987-04-27Type 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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