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Details for New Drug Application (NDA): 050557

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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. Seven suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.

Summary for NDA: 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 0187-5205-46 1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR
BENZAMYCIN
benzoyl peroxide; erythromycin
GEL;TOPICAL 050557 NDA AUTHORIZED GENERIC Perrigo New York Inc 45802-083 45802-083-02 1 KIT in 1 BOX (45802-083-02) * .8 g in 1 VIAL, PLASTIC * 20 g in 1 JAR

Summary for product number 001

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


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