Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061905
Company: AZURITY

Products on ANDA 061905

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	TABLET;ORAL	Discontinued	None	No	No
E.E.S. 400	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE	TABLET;ORAL	Prescription	BX	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 061905

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1982	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-50	Labeling-Package Insert		Label is not available on this site.
10/31/2013	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf
02/25/2009	SUPPL-45	Labeling		Label is not available on this site.
02/25/2009	SUPPL-44	Labeling		Label is not available on this site.
07/21/2006	SUPPL-43	Labeling		Label is not available on this site.
12/09/2002	SUPPL-40	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
12/09/2002	SUPPL-39	Manufacturing (CMC)-Control		Label is not available on this site.
01/03/2003	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
01/17/2001	SUPPL-37	Labeling		Label is not available on this site.
04/20/1998	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
11/16/2000	SUPPL-35	Labeling		Label is not available on this site.
07/29/1994	SUPPL-34	Labeling		Label is not available on this site.
07/29/1994	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
08/18/1992	SUPPL-32	Labeling		Label is not available on this site.
08/18/1992	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
04/03/1989	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 061905

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2013	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/061639s032,061905s049lbl.pdf

Therapeutic Equivalents for ANDA 061905

E.E.S. 400

There are no Therapeutic Equivalents.