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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050688
Company: SANKYO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BANAN CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
BANAN CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/10/2000 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000 SUPPL-12 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000 SUPPL-11 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
02/10/2000 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50687S4_Banan_prntlbl.pdf
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