FDA NDA · NDA019832

SULFAMYLON

Sponsor: MYLAN INSTITUTIONAL

APPLICATION

NDA019832

TYPE

NDA

ORIGINAL APPROVAL

1998-06-05

LATEST ACTION

2015-01-20

ROUTE

TOPICAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Discontinued

Products

SULFAMYLON · ReferenceDiscontinued

MAFENIDE ACETATE 5% · FOR SOLUTION · TOPICAL

2015-01-20Manufacturing (CMC) · Supplement 14 · standardAP

2013-06-18Manufacturing (CMC) · Supplement 13 · standardAP

2002-12-18Manufacturing (CMC) · Supplement 6 · standardAP

2002-05-09Manufacturing (CMC) · Supplement 5 · standardAP

2001-09-17Manufacturing (CMC) · Supplement 4 · standardAP

2001-07-12Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP

2001-07-12Labeling · Supplement 2 · standard — Letter ↗AP

1998-09-25Manufacturing (CMC) · Supplement 1 · standardAP

1998-06-05Type 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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