Drugs@FDA: FDA Approved Drug Products

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

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 204835 AUROBINDO PHARMA LTD
CEFIXIME CEFIXIME 100MG/5ML FOR SUSPENSION;ORAL Prescription No AB 206938 BELCHER PHARMS LLC
SUPRAX CEFIXIME 100MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065129 LUPIN PHARMS

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 204835 AUROBINDO PHARMA LTD
CEFIXIME CEFIXIME 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 206938 BELCHER PHARMS LLC
SUPRAX CEFIXIME 200MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065355 LUPIN PHARMS

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