Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 061639
Company: ARBOR PHARMS LLC

Products on ANDA 61639

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
E.E.S. 200	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUSPENSION;ORAL	Discontinued	None	No	No
E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	SUSPENSION;ORAL	Discontinued	None	No	No

Labels for ANDA 061639

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2013	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf