APPLICATION
ANDA076363
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-31
LATEST ACTION
2020-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DIGOXINDiscontinued
DIGOXIN 0.125MG · TABLET · ORAL
DIGOXINDiscontinued
DIGOXIN 0.25MG · TABLET · ORAL
Approval history
2020-10-07Labeling · Supplement 26 · standardAP
2020-10-07Labeling · Supplement 32 · standardAP
2020-10-07Labeling · Supplement 30 · standardAP
2020-10-07Labeling · Supplement 22 · standardAP
2020-10-07Labeling · Supplement 19 · standardAP
2020-10-07Labeling · Supplement 25 · standardAP
2010-07-06Labeling · Supplement 12AP
2007-06-14Manufacturing (CMC) · Supplement 8AP
2003-01-31OriginalAP
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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