Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065385
Company: LYNE

Products on ANDA 065385

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	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065385

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2015	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 065385

ERYTHROMYCIN AND BENZOYL PEROXIDE

GEL;TOPICAL; 5%;3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZAMYCIN	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Prescription	Yes	AB	050557	VALEANT INTL
ERYTHROMYCIN AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Prescription	No	AB	065385	LYNE