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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090031
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None 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
01/14/2009 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
06/02/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090031Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/090031Orig1s005ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/02/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/090031Orig1s005lbl.pdf
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