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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211975
Company: TORRENT

Products on ANDA 211975

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	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211975

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2024	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211975Orig1s006ltr.pdf

Therapeutic Equivalents for ANDA 211975

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	CARNEGIE
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; 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	CARNEGIE
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

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	CARNEGIE
ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	210954	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	333MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211975	TORRENT

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