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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060359
Company: AZURITY

Products on ANDA 060359

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROCIN STEARATE	ERYTHROMYCIN STEARATE	EQ 250MG BASE	TABLET;ORAL	Prescription	None	No	Yes
ERYTHROCIN STEARATE	ERYTHROMYCIN STEARATE	EQ 125MG BASE	TABLET;ORAL	Discontinued	None	No	No
ERYTHROCIN STEARATE	ERYTHROMYCIN STEARATE	EQ 500MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 060359

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/1964	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
07/24/2013	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/04/2013	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/060359s028lbl.pdf
09/18/2009	SUPPL-27	Labeling		Label is not available on this site.
07/02/2009	SUPPL-25	Labeling		Label is not available on this site.
03/17/2004	SUPPL-22	Labeling		Label is not available on this site.
01/03/2003	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
02/09/2001	SUPPL-19	Labeling		Label is not available on this site.
07/11/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
10/26/2000	SUPPL-17	Labeling		Label is not available on this site.
04/20/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 060359

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2013	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/060359s028lbl.pdf

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