Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065380
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUPRAX CEFIXIME 100MG TABLET, CHEWABLE;ORAL Prescription None No No
SUPRAX CEFIXIME 150MG TABLET, CHEWABLE;ORAL Prescription None No No
SUPRAX CEFIXIME 200MG TABLET, CHEWABLE;ORAL Prescription None 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
10/25/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/065380s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

03/29/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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