APPLICATION
ANDA040282
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-23
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DIGOXINPrescription
DIGOXIN 0.25MG · TABLET · ORAL
DIGOXINPrescription
DIGOXIN 0.125MG · TABLET · ORAL
Approval history
2026-02-09Labeling · Supplement 26 · standardAP
2020-09-10Labeling · Supplement 23 · standardAP
2019-01-28Labeling · Supplement 21 · standardAP
2016-11-02Labeling · Supplement 16 · standardAP
2002-06-12Manufacturing (CMC) · Supplement 6AP
2001-04-18Manufacturing (CMC) · Supplement 5AP
2001-04-18Manufacturing (CMC) · Supplement 4AP
2001-02-07Labeling · Supplement 3AP
2001-02-07Manufacturing (CMC) · Supplement 1AP
2000-10-31Labeling · Supplement 2AP
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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