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FDA NDA · NDA019260

PSORCON

Sponsor: PFIZER

APPLICATION
NDA019260
TYPE
NDA
ORIGINAL APPROVAL
1985-08-28
LATEST ACTION
2017-10-25
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

PSORCON · ReferenceDiscontinued
DIFLORASONE DIACETATE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2017-10-25Labeling · Supplement 9 · standard — Label ↗AP
2003-04-24Labeling · Supplement 7 · standard — Label ↗AP
1997-10-10Manufacturing (CMC) · Supplement 6 · standardAP
1996-05-17Manufacturing (CMC) · Supplement 5 · standardAP
1993-03-25Manufacturing (CMC) · Supplement 3 · standardAP
1986-10-14Labeling · Supplement 2AP
1986-03-12Manufacturing (CMC) · Supplement 1 · standardAP
1985-08-28Type 3 - New Dosage Form · 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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