FDA NDA · NDA018738

SULCONAZOLE NITRATE

Sponsor: JOURNEY

APPLICATION

NDA018738

TYPE

NDA

ORIGINAL APPROVAL

1985-08-30

LATEST ACTION

2014-05-19

ROUTE

TOPICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

EXELDERM · ReferenceDiscontinued

SULCONAZOLE NITRATE 1% · SOLUTION · TOPICAL

2014-05-19Manufacturing (CMC) · Supplement 14 · standardAP

2009-07-08Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP

2003-05-30Labeling · Supplement 7 · standard — Label ↗AP

2001-10-19Manufacturing (CMC) · Supplement 8 · standardAP

1993-09-22Manufacturing (CMC) · Supplement 6 · standardAP

1991-03-08Manufacturing (CMC) · Supplement 5 · standardAP

1991-02-14Manufacturing (CMC) · Supplement 4 · standardAP

1990-08-20Labeling · Supplement 2AP

1990-07-20Manufacturing (CMC) · Supplement 3 · standardAP

1986-12-18Manufacturing (CMC) · Supplement 1 · standardAP

1985-08-30Type 1 - New Molecular Entity · Original · standard — Review ↗AP

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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