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FDA ANDA · ANDA071425

DESOWEN

Sponsor: GALDERMA LABS LP

APPLICATION
ANDA071425
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-15
LATEST ACTION
1997-01-31
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

DESOWENDiscontinued
DESONIDE 0.05% · OINTMENT · TOPICAL

Approval history

1997-01-31Labeling · Supplement 6AP
1994-11-01Manufacturing (CMC) · Supplement 5AP
1993-05-19Labeling · Supplement 4AP
1992-10-30Labeling · Supplement 3AP
1991-11-06Labeling · Supplement 2AP
1989-08-29Manufacturing (CMC) · Supplement 1AP
1988-06-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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