U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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

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.

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 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
Back to Top