FDA NDA · NDA021794

DAPSONE

Sponsor: ALMIRALL

APPLICATION

NDA021794

TYPE

NDA

ORIGINAL APPROVAL

2005-07-07

LATEST ACTION

2018-05-18

ROUTE

TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Prescription

Products

ACZONE · ReferencePrescription

DAPSONE 5% · GEL · TOPICAL

2018-05-18Labeling · Supplement 16 · standard — Letter ↗AP

2015-09-03Manufacturing (CMC) · Supplement 14 · standardAP

2015-07-09Labeling · Supplement 13 · standard — Label ↗AP

2013-11-08Labeling · Supplement 12 · unknownAP

2013-10-31Manufacturing (CMC) · Supplement 10 · standardAP

2013-10-03Manufacturing (CMC) · Supplement 11 · standardAP

2009-03-26Manufacturing (CMC) · Supplement 6 — Label ↗AP

2008-03-14Efficacy · Supplement 5 · standard — Label ↗AP

2005-07-07Type 3 - New Dosage Form · Original · standard — Letter ↗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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