APPLICATION
ANDA205740
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-21
LATEST ACTION
2019-05-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ENTECAVIRPrescription
ENTECAVIR 1MG · TABLET · ORAL
ENTECAVIRPrescription
ENTECAVIR 0.5MG · TABLET · ORAL
Approval history
2019-05-31Labeling · Supplement 2 · standardAP
2019-05-31Labeling · Supplement 3 · standardAP
2015-08-21UNKNOWN · Original · standardAP
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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