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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
US Department of Justice
US Army
Express Scripts

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065385

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NDA 065385 describes ERYTHROMYCIN AND BENZOYL PEROXIDE, which is a drug marketed by Lyne and Tolmar and is included in two NDAs. It is available from three suppliers. Additional details are available on the ERYTHROMYCIN AND BENZOYL PEROXIDE profile page.

The generic ingredient in ERYTHROMYCIN AND BENZOYL PEROXIDE 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 065385
Ingredient:benzoyl peroxide; erythromycin
Formulation / Manufacturing:see details
Pharmacology for NDA: 065385
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 065385
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERYTHROMYCIN AND BENZOYL PEROXIDE benzoyl peroxide; erythromycin GEL;TOPICAL 065385 ANDA Lyne Laboratories, Inc. 0374-5060 0374-5060-01 23.3 g in 1 VIAL, PLASTIC (0374-5060-01)
ERYTHROMYCIN AND BENZOYL PEROXIDE benzoyl peroxide; erythromycin GEL;TOPICAL 065385 ANDA Lyne Laboratories, Inc. 0374-5060 0374-5060-02 46.6 g in 1 VIAL, PLASTIC (0374-5060-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;3%
Approval Date:Sep 18, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Chinese Patent Office
Express Scripts

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