Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065112
Company: ENCUBE

Products on ANDA 065112

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065112

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2004	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065112_ORIGINAL APPROVAL_PACKAGE.pdf