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Serving leading biopharmaceutical companies globally:

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Generated: November 24, 2017

DrugPatentWatch Database Preview

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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 050769

Ingredient-typeMacrolides
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 70363-007-60 60 POUCH in 1 CARTON (70363-007-60) > .8 g in 1 POUCH

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Merck
Covington
Express Scripts
Cantor Fitzgerald
Novartis
Chubb
QuintilesIMS
McKesson
Moodys
Cerilliant

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