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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050557

BENZAMYCIN (BENZOYL PEROXIDE; ERYTHROMYCIN)
5%;3%
Marketing Status: Prescription
Active Ingredient: BENZOYL PEROXIDE; ERYTHROMYCIN
Proprietary Name: BENZAMYCIN
Dosage Form; Route of Administration: GEL; TOPICAL
Strength: 5%;3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050557
Product Number: 001
Approval Date: Oct 26, 1984
Applicant Holder Full Name: VALEANT INTERNATIONAL SRL
Marketing Status:  Prescription
Patent and Exclusivity Information
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