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FDA ANDA · ANDA065462

CEFPODOXIME PROXETIL

Sponsor: SANDOZ

APPLICATION
ANDA065462
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-28
LATEST ACTION
2014-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CEFPODOXIME PROXETILPrescription
CEFPODOXIME PROXETIL EQ 100MG BASE · TABLET · ORAL
CEFPODOXIME PROXETILPrescription
CEFPODOXIME PROXETIL EQ 200MG BASE · TABLET · ORAL

Approval history

2014-02-05Labeling · Supplement 5 · standardLabelAP
2008-05-28OriginalAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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