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FDA ANDA · ANDA206530

FAMOTIDINE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA206530
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-22
LATEST ACTION
2019-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FAMOTIDINEPrescription
FAMOTIDINE 20MG · TABLET · ORAL
FAMOTIDINEPrescription
FAMOTIDINE 40MG · TABLET · ORAL

Approval history

2019-10-22Labeling · Supplement 4 · standardAP
2019-10-22Labeling · Supplement 2 · standardAP
2015-12-22UNKNOWN · Original · standardLetterAP
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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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