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FDA ANDA · ANDA091612

TENOFOVIR DISOPROXIL FUMARATE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA091612
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-18
LATEST ACTION
2017-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TENOFOVIR DISOPROXIL FUMARATEPrescription
TENOFOVIR DISOPROXIL FUMARATE 200MG · TABLET · ORAL
TENOFOVIR DISOPROXIL FUMARATEPrescription
TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
TENOFOVIR DISOPROXIL FUMARATEPrescription
TENOFOVIR DISOPROXIL FUMARATE 250MG · TABLET · ORAL
TENOFOVIR DISOPROXIL FUMARATEPrescription
TENOFOVIR DISOPROXIL FUMARATE 150MG · TABLET · ORAL

Approval history

2018-01-26UNKNOWN · Supplement 1 · unknownTA
2017-10-24Labeling · Supplement 2 · standardAP
2017-10-24Labeling · Supplement 3 · standardAP
2015-03-18OriginalLetterAP
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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