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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216066
Company: ALKEM LABS LTD

Products on ANDA 216066

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216066

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/13/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216066

ERYTHROMYCIN

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	215661	ALEMBIC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	216066	ALKEM LABS LTD
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	209720	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	061621	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	213628	CADILA PHARMS LTD
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	214549	TEVA PHARMS USA INC
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	212015	TORRENT
ERYTHROMYCIN	ERYTHROMYCIN	250MG	TABLET;ORAL	Prescription	No	AB	212693	ZYDUS LIFESCIENCES

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	215661	ALEMBIC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	216066	ALKEM LABS LTD
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	209720	AMNEAL PHARMS CO
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	061621	AZURITY
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	213628	CADILA PHARMS LTD
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	214549	TEVA PHARMS USA INC
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	212015	TORRENT
ERYTHROMYCIN	ERYTHROMYCIN	500MG	TABLET;ORAL	Prescription	No	AB	212693	ZYDUS LIFESCIENCES

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