APPLICATION
ANDA077002
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-30
LATEST ACTION
2020-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIGOXINPrescription
DIGOXIN 0.125MG · TABLET · ORAL
DIGOXINPrescription
DIGOXIN 0.25MG · TABLET · ORAL
Approval history
2020-10-07Labeling · Supplement 20 · standardAP
2020-10-07Labeling · Supplement 15 · standardAP
2020-10-07Labeling · Supplement 22 · standardAP
2016-11-12Labeling · Supplement 12 · standardAP
2016-11-12Labeling · Supplement 9 · standardAP
2016-11-12Labeling · Supplement 11 · standardAP
2015-02-23Manufacturing (CMC) · Supplement 4AP
2011-12-30Labeling · Supplement 6AP
2007-10-30OriginalAP
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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