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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206939
Company: BELCHER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFIXIME CEFIXIME 500MG/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
02/06/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206939Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206939Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/06/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206939Orig1s000lbl.pdf

CEFIXIME

FOR SUSPENSION;ORAL; 500MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFIXIME CEFIXIME 500MG/5ML FOR SUSPENSION;ORAL Prescription No AB 206939 BELCHER
SUPRAX CEFIXIME 500MG/5ML FOR SUSPENSION;ORAL Prescription Yes AB 202091 LUPIN LTD
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