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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210954
Company: AMNEAL PHARMS CO

Products on ANDA 210954

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210954

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/02/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210954

ERYTHROMYCIN

TABLET, DELAYED RELEASE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERY-TAB	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	062298	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	210954	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211975	TORRENT

TABLET, DELAYED RELEASE;ORAL; 333MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERY-TAB	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	062298	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	210954	AMNEAL PHARMS CO

TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERY-TAB	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	062298	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	210954	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211975	TORRENT

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