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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050297
Company: AZURITY

Products on NDA 050297

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/1970	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2012	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050297s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050297Orig1s031ltr.pdf
12/10/2008	SUPPL-30	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s068, 050297s030ltr.pdf
11/04/2010	SUPPL-29	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050207s067,050297s029ltr.pdf
05/22/2008	SUPPL-28	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050297s028ltr.pdf
01/05/2008	SUPPL-27	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050297s027ltr.pdf
03/12/2004	SUPPL-24	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50611slr024,50297slr024,50207slr061ltr.pdf
08/10/2006	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050207s058, 050297s021LTR.pdf
04/25/2002	SUPPL-19	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf
02/04/2000	SUPPL-18	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s55_50-297s018_50-611s018_Erthromycin.cfm
04/14/1997	SUPPL-17	Labeling		Label is not available on this site.

Labels for NDA 050297

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/15/2012	SUPPL-31	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050297s031lbl.pdf
12/10/2008	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf
01/05/2008	SUPPL-27	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s027lbl.pdf
08/10/2006	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf

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