Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Medtronic
Daiichi Sankyo
US Department of Justice
Julphar
Chinese Patent Office
Chubb
Mallinckrodt
UBS

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050557

« Back to Dashboard

NDA 050557 describes BENZAMYCIN, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from four suppliers. Additional details are available on the BENZAMYCIN profile page.

The generic ingredient in BENZAMYCIN 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 050557
Tradename:BENZAMYCIN
Applicant:Valeant Intl
Ingredient:benzoyl peroxide; erythromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050557
Ingredient-typeMacrolides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZAMYCIN benzoyl peroxide; erythromycin GEL;TOPICAL 050557 NDA Valeant Pharmaceuticals North America LLC 0187-5205 N 0187-5205-46
BENZAMYCIN benzoyl peroxide; erythromycin GEL;TOPICAL 050557 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-083 E 45802-083-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;3%
Approval Date:Oct 26, 1984TE:ABRLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Merck
Chubb
Farmers Insurance
Medtronic
Moodys
Boehringer Ingelheim
Fuji
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.