← FDA DRUG APPROVALS

FDA NDA · NDA018737

EXELDERM

sulconazole nitrate

Sponsor: JOURNEY

APPLICATION
NDA018737
TYPE
NDA
ORIGINAL APPROVAL
1989-02-28
LATEST ACTION
2013-11-26
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

EXELDERM · ReferencePrescription
SULCONAZOLE NITRATE 1% · CREAM · TOPICAL

Approval history

2013-11-26Manufacturing (CMC) · Supplement 7 · standardAP
2003-05-30Labeling · Supplement 3 · standard — Letter ↗AP
2001-10-19Manufacturing (CMC) · Supplement 4 · standardAP
1991-05-13Manufacturing (CMC) · Supplement 1 · standardAP
1989-02-28Type 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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