Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065355
Company: LUPIN PHARMS

Products on ANDA 065355

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUPRAX	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065355

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2016	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
03/29/2013	SUPPL-18	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065355

SUPRAX

FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	206938	AJENAT PHARMS
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211775	ALKEM LABS LTD
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	204835	AUROBINDO PHARMA LTD
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	218691	FDC LTD
SUPRAX	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065355	LUPIN PHARMS