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FDA NDA · NDA018594

DESOXIMETASONE

Sponsor: TARO

APPLICATION
NDA018594
TYPE
NDA
ORIGINAL APPROVAL
1985-01-17
LATEST ACTION
2015-11-06
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

TOPICORT · ReferencePrescription
DESOXIMETASONE 0.05% · OINTMENT · TOPICAL

Approval history

2015-11-06Manufacturing (CMC) · Supplement 12 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 10 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 11 · standardAP
2014-05-12Manufacturing (CMC) · Supplement 9 · standardAP
2012-12-07Manufacturing (CMC) · Supplement 8 · standardLabelAP
2010-05-14Labeling · Supplement 7 · standardLabelAP
1994-07-26Manufacturing (CMC) · Supplement 5 · standardAP
1993-10-13Manufacturing (CMC) · Supplement 4 · standardAP
1988-11-08Manufacturing (CMC) · Supplement 2 · standardAP
1988-02-19Manufacturing (CMC) · Supplement 1 · standardAP
1985-01-17Type 3 - New Dosage Form · Original · standardAP
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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