FDA NDA · NDA019931

SODIUM SULFACETAMIDE

Sponsor: BAUSCH

APPLICATION

NDA019931

TYPE

NDA

ORIGINAL APPROVAL

1996-12-23

LATEST ACTION

2016-02-16

ROUTE

TOPICAL

DOSAGE FORM

LOTION

MARKETING STATUS

Prescription

Products

KLARON · ReferencePrescription

SULFACETAMIDE SODIUM 10% · LOTION · TOPICAL

2016-02-16Manufacturing (CMC) · Supplement 24 · standardAP

2015-10-27Manufacturing (CMC) · Supplement 23 · standardAP

2014-12-05Manufacturing (CMC) · Supplement 22 · standardAP

2010-07-02Labeling · Supplement 19 · unknown — Letter ↗AP

2003-02-21Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP

2002-10-09Manufacturing (CMC) · Supplement 6 · standardAP

2002-10-09Manufacturing (CMC) · Supplement 7 · standardAP

2002-09-12Manufacturing (CMC) · Supplement 4 · standardAP

2002-09-12Manufacturing (CMC) · Supplement 5 · standardAP

2002-03-26Manufacturing (CMC) · Supplement 3 · standardAP

1999-06-15Manufacturing (CMC) · Supplement 1 · standardAP

1996-12-23Type 3 - New Dosage Form · 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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