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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Express Scripts
US Department of Justice
Queensland Health
Colorcon
Deloitte
Johnson and Johnson
Teva

Generated: June 22, 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
Tradename:ERYTHROMYCIN AND BENZOYL PEROXIDE
Applicant:Lyne
Ingredient:benzoyl peroxide; erythromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065385
Ingredient-typeMacrolides
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 N 0374-5060-01
ERYTHROMYCIN AND BENZOYL PEROXIDE benzoyl peroxide; erythromycin GEL;TOPICAL 065385 ANDA Lyne Laboratories, Inc. 0374-5060 N 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 hundreds of leading biopharmaceutical companies globally:

Julphar
Merck
QuintilesIMS
Fish and Richardson
Daiichi Sankyo
Farmers Insurance
Dow
Boehringer Ingelheim
US Department of Justice

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