FDA NDA · NDA050769

AKTIPAK

Sponsor: BIOFRONTERA

APPLICATION

NDA050769

TYPE

NDA

ORIGINAL APPROVAL

2000-11-27

LATEST ACTION

2016-09-29

ROUTE

TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Discontinued

Products

AKTIPAK · ReferenceDiscontinued

BENZOYL PEROXIDE 5%, ERYTHROMYCIN 3% · GEL · TOPICAL

2016-09-29Labeling · Supplement 17 · standard — Letter ↗AP

2015-03-16Manufacturing (CMC) · Supplement 16 · standardAP

2002-11-01Manufacturing (CMC) · Supplement 8 · standardAP

2002-10-23Manufacturing (CMC) · Supplement 6 · standardAP

2002-09-03Manufacturing (CMC) · Supplement 5 · standardAP

2002-08-28Manufacturing (CMC) · Supplement 7 · standardAP

2001-10-17Manufacturing (CMC) · Supplement 4 · standardAP

2001-10-17Manufacturing (CMC) · Supplement 3 · standardAP

2001-06-29Manufacturing (CMC) · Supplement 2 · standardAP

2001-03-22Manufacturing (CMC) · Supplement 1 · standardAP

2000-11-27Type 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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