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FDA NDA · NDA019716

DIPROLENE

Sponsor: ORGANON

APPLICATION
NDA019716
TYPE
NDA
ORIGINAL APPROVAL
1988-08-01
LATEST ACTION
2019-05-01
ROUTE
TOPICAL
DOSAGE FORM
LOTION, AUGMENTED
MARKETING STATUS
Discontinued

Products

DIPROLENE · ReferenceDiscontinued
BETAMETHASONE DIPROPIONATE EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION, AUGMENTED · TOPICAL

Approval history

2019-05-01Labeling · Supplement 33 · standard — Letter ↗AP
2018-03-28Labeling · Supplement 32 · standard — Label ↗AP
2014-08-13Labeling · Supplement 30 · standard — Label ↗AP
2006-08-28Efficacy · Supplement 22 · standard — Label ↗AP
2006-04-24Labeling · Supplement 21 · standard — Letter ↗AP
2005-10-07Labeling · Supplement 6 — Letter ↗AP
2001-05-11Manufacturing (CMC) · Supplement 12 · standardAP
2000-09-07Manufacturing (CMC) · Supplement 11 · standardAP
1999-05-14Manufacturing (CMC) · Supplement 10 · standardAP
1998-07-31Manufacturing (CMC) · Supplement 9 · standardAP
1998-06-15Manufacturing (CMC) · Supplement 8 · standardAP
1996-01-25Manufacturing (CMC) · Supplement 7 · standardAP
1992-07-01Manufacturing (CMC) · Supplement 5 · standardAP
1990-08-01Manufacturing (CMC) · Supplement 4 · standardAP
1989-05-24Labeling · Supplement 3AP
1989-04-06Manufacturing (CMC) · Supplement 2 · standardAP
1988-08-01Type 3 - New Dosage Form · Original · standardAP
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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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