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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050207
Company: AZURITY

Products on NDA 050207

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	AB	Yes	No
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	AB	Yes	Yes
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050207

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/1965	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
04/23/2018	SUPPL-74	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050207Orig1s074,050611Orig1s036ltr.pdf
08/17/2017	SUPPL-73	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/2017/050207s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050207Orig1s073ltr.pdf
02/02/2012	SUPPL-71	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050207s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050207s071,050611s035ltr.pdf
12/10/2008	SUPPL-68	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-67	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-66	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s066ltr.pdf
01/05/2008	SUPPL-65	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050207s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050207s065ltr.pdf
01/26/2011	SUPPL-64	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050207s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050207s064ltr.pdf
03/12/2004	SUPPL-61	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-58	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-57	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50207s057.pdf
11/24/1999	SUPPL-56	Manufacturing (CMC)-Control		Label is not available on this site.
02/04/2000	SUPPL-55	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s055_Erythromycin.cfm
02/04/2000	SUPPL-54	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-207s054s055_Erythromycin.cfm
05/09/1997	SUPPL-53	Manufacturing (CMC)-Control		Label is not available on this site.
04/29/1997	SUPPL-52	Manufacturing (CMC)-Control		Label is not available on this site.
04/14/1997	SUPPL-51	Labeling		Label is not available on this site.
04/14/1997	SUPPL-50	Labeling		Label is not available on this site.

Labels for NDA 050207

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2018	SUPPL-74	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050207s074,050611s036lbl.pdf
08/17/2017	SUPPL-73	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/2017/050207s073lbl.pdf
02/02/2012	SUPPL-71	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050207s071lbl.pdf
01/26/2011	SUPPL-64	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050207s064lbl.pdf
12/10/2008	SUPPL-68	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050297s030,050207s068lbl.pdf
01/05/2008	SUPPL-65	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050207s065lbl.pdf
08/10/2006	SUPPL-58	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050207s058,050297s021lbl.pdf

Therapeutic Equivalents for NDA 050207

E.E.S.

GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	211204	AMNEAL PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	216212	CADILA PHARMS LTD

ERYPED

GRANULE;ORAL; EQ 400MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	211204	AMNEAL PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 400MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	216212	CADILA PHARMS LTD

GRANULE;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
E.E.S.	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYPED	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	Yes	AB	050207	AZURITY
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	211204	AMNEAL PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	062055	ANI PHARMS
ERYTHROMYCIN ETHYLSUCCINATE	ERYTHROMYCIN ETHYLSUCCINATE	EQ 200MG BASE/5ML	GRANULE;ORAL	Prescription	No	AB	216212	CADILA PHARMS LTD

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