APPLICATION
ANDA205824
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-25
LATEST ACTION
2023-08-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ENTECAVIRDiscontinued
ENTECAVIR 1MG · TABLET · ORAL
ENTECAVIRDiscontinued
ENTECAVIR 0.5MG · TABLET · ORAL
Approval history
2023-08-25Labeling · Supplement 4 · standardAP
2019-04-23Labeling · Supplement 2 · standardAP
2019-04-23Labeling · Supplement 3 · standardAP
2017-08-25UNKNOWN · 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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