Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204835
Company: AUROBINDO PHARMA LTD

Products on ANDA 204835

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No
CEFIXIME	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204835

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204835Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204835

CEFIXIME

FOR SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211775	ALKEM LABS LTD
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	204835	AUROBINDO PHARMA LTD
CEFIXIME	CEFIXIME	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	206938	BELCHER

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	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	206938	BELCHER
SUPRAX	CEFIXIME	200MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065355	LUPIN PHARMS