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FDA ANDA · ANDA206652

ENTECAVIR

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA206652
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-12
LATEST ACTION
2020-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ENTECAVIRPrescription
ENTECAVIR 0.5MG · TABLET · ORAL
ENTECAVIRPrescription
ENTECAVIR 1MG · TABLET · ORAL

Approval history

2020-06-16Labeling · Supplement 6 · standardAP
2019-04-16Labeling · Supplement 2 · standardAP
2019-04-16Labeling · Supplement 5 · standardAP
2019-04-16Labeling · Supplement 3 · standardAP
2016-09-30Manufacturing (CMC) · Supplement 1 · unknownAP
2015-11-12UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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