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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213568
Company: AUROBINDO PHARMA

Products on ANDA 213568

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213568

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213568Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213568

CEPHALEXIN

FOR SUSPENSION;ORAL; EQ 125MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210221	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213568	AUROBINDO PHARMA
CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065234	LUPIN
CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	062703	TEVA
CEPHALEXIN	CEPHALEXIN	EQ 125MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065336	YUNG SHIN PHARM

FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210221	ALKEM LABS LTD
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	213568	AUROBINDO PHARMA
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065234	LUPIN
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	062703	TEVA
CEPHALEXIN	CEPHALEXIN	EQ 250MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065336	YUNG SHIN PHARM

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