Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050557
Company: VALEANT INTL

Products on NDA 50557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZAMYCIN	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Labels for NDA 050557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2003	SUPPL-25	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050557s025lbl.pdf