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FDA ANDA · ANDA091231

PANTOPRAZOLE SODIUM

Sponsor: APOTEX

APPLICATION
ANDA091231
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-19
LATEST ACTION
2016-05-27
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 40MG BASE · TABLET, DELAYED RELEASE · ORAL
PANTOPRAZOLE SODIUMPrescription
PANTOPRAZOLE SODIUM EQ 20MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2016-05-27Labeling · Supplement 3 · standardAP
2011-01-19OriginalAP
VIEW ON DRUGS@FDA ↗

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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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