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FDA NDA · NDA018702

ACLOVATE

Sponsor: FOUGERA

APPLICATION
NDA018702
TYPE
NDA
ORIGINAL APPROVAL
1982-12-14
LATEST ACTION
2011-04-05
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

ACLOVATE · ReferenceDiscontinued
ALCLOMETASONE DIPROPIONATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2011-04-05Labeling · Supplement 11 · unknown — Label ↗AP
2003-04-02Labeling · Supplement 7 · standard — Label ↗AP
2002-07-26Manufacturing (CMC) · Supplement 8 · standard — Letter ↗AP
1996-04-26Labeling · Supplement 5 · standardAP
1994-06-22Manufacturing (CMC) · Supplement 6 · standardAP
1994-06-07Manufacturing (CMC) · Supplement 4 · standardAP
1991-01-16Manufacturing (CMC) · Supplement 3 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 2 · standardAP
1983-11-07Labeling · Supplement 1AP
1982-12-14Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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