Aktipak

NDA 50769, held by Biofrontera. Benzoyl Peroxide; Erythromycin.

As of Nov 14, 2026, NDA 50769 (Aktipak), held by Biofrontera, was first approved by FDA on Nov 27, 2000, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 27, 2000
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Nov 27, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aktipak5%;3% · gel;topical	Benzoyl Peroxide; Erythromycin	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Sep 29, 2016	Supplement 17Labeling · Standard review	Approved	Label Letter
Mar 16, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 1, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 23, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 3, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 28, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 17, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 17, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 29, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 22, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 27, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 50769
Drugs@FDA: Overview at FDA
Company: Biofrontera

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters