Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065462
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET;ORAL Prescription AB No No
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET;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
05/28/2008 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
02/05/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065462Orig1s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/05/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065462s005lbl.pdf

CEFPODOXIME PROXETIL

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET;ORAL Prescription No AB 065370 AUROBINDO PHARMA
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET;ORAL Prescription No AB 065388 ORCHID HLTHCARE
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET;ORAL Prescription No AB 065462 SANDOZ

TABLET;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET;ORAL Prescription No AB 065370 AUROBINDO PHARMA
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET;ORAL Prescription No AB 065388 ORCHID HLTHCARE
CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET;ORAL Prescription No AB 065462 SANDOZ

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