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Details for New Drug Application (NDA): 065112

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NDA 065112 describes ERYTHROMYCIN AND BENZOYL PEROXIDE, which is a drug marketed by Tolmar and Lyne and is included in two NDAs. It is available from two 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. Six suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.

Summary for NDA: 065112

Suppliers and Packaging for NDA: 065112

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
benzoyl peroxide; erythromycin
GEL;TOPICAL 065112 ANDA Sandoz Inc. 0781-7054 0781-7054-49 1 KIT in 1 CARTON (0781-7054-49) * .8 g in 1 VIAL, PLASTIC (0781-8054-01) * 20 g in 1 JAR (0781-9054-22)
benzoyl peroxide; erythromycin
GEL;TOPICAL 065112 ANDA Sandoz Inc. 0781-7094 0781-7094-59 1 KIT in 1 CARTON (0781-7094-59) * 1.6 g in 1 VIAL, PLASTIC (0781-8094-02) * 40 g in 1 JAR (0781-9094-44)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength5%;3%
Approval Date:Mar 29, 2004TE:ABRLD:No

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