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Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 061639

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200	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION;ORAL	Discontinued	None	No	No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400	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061639

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/1973	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2015	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
10/31/2013	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf
02/25/2009	SUPPL-29	Labeling		Label is not available on this site.
02/25/2009	SUPPL-28	Labeling		Label is not available on this site.
07/21/2006	SUPPL-26	Labeling		Label is not available on this site.
01/17/2001	SUPPL-23	Labeling		Label is not available on this site.
11/16/2000	SUPPL-22	Labeling		Label is not available on this site.
11/28/1997	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/26/1991	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.

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

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