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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Chinese Patent Office
US Army
Harvard Business School

Generated: February 23, 2018

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Details for New Drug Application (NDA): 050769

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NDA 050769 describes AKTIPAK, which is a drug marketed by Cutanea and is included in one NDA. It is available from one supplier. Additional details are available on the AKTIPAK profile page.

The generic ingredient in AKTIPAK is benzoyl peroxide; erythromycin. There are seventeen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.
Summary for 050769
Ingredient:benzoyl peroxide; erythromycin
Formulation / Manufacturing:see details
Pharmacology for NDA: 050769
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050769
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKTIPAK benzoyl peroxide; erythromycin GEL;TOPICAL 050769 NDA Cutanea Life Sciences, Inc. 70363-007 N 70363-007-04
AKTIPAK benzoyl peroxide; erythromycin GEL;TOPICAL 050769 NDA Cutanea Life Sciences, Inc. 70363-007 N 70363-007-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;3%
Approval Date:Nov 27, 2000TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo

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