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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210534
Company: ALKEM LABS LTD

Products on ANDA 210534

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210534

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210534

CEFDINIR

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210534	ALKEM LABS LTD
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065429	ANDA REPOSITORY
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065473	AUROBINDO PHARMA
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065259	LUPIN
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065337	SANDOZ
CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065332	TEVA PHARMS

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210534	ALKEM LABS LTD
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065429	ANDA REPOSITORY
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065473	AUROBINDO PHARMA
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065259	LUPIN
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065337	SANDOZ
CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065332	TEVA PHARMS

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