APPLICATION
ANDA078556
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-20
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIGOXINDiscontinued
DIGOXIN 0.25MG · TABLET · ORAL
DIGOXINDiscontinued
DIGOXIN 0.125MG · TABLET · ORAL
Approval history
2026-02-09Labeling · Supplement 26 · standardAP
2020-11-12Labeling · Supplement 22 · standardAP
2020-11-12Labeling · Supplement 21 · standardAP
2020-11-12Labeling · Supplement 13 · standardAP
2020-11-12Labeling · Supplement 18 · standardAP
2015-04-06Labeling · Supplement 10 · standardAP
2015-04-06Labeling · Supplement 5AP
2010-04-26Labeling · Supplement 2AP
2009-07-20OriginalAP
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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