Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Check market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065385

« Back to Dashboard
NDA 065385 describes ERYTHROMYCIN AND BENZOYL PEROXIDE, which is a drug marketed by Tolmar and Lyne 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. Seven suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.

Summary for NDA: 065385

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
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)
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)

Summary for product number 001

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

Complete Access Available with Subscription
« Back to Dashboard

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

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.