Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218817
Company: AUROBINDO PHARMA LTD

Products on ANDA 218817

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218817

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218817

CEPHALEXIN

TABLET;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	218947	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE	TABLET;ORAL	Prescription	No	AB	218817	AUROBINDO PHARMA LTD

TABLET;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	218947	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	TABLET;ORAL	Prescription	No	AB	218817	AUROBINDO PHARMA LTD