APPLICATION
ANDA083391
TYPE
ANDA
ORIGINAL APPROVAL
1975-10-24
LATEST ACTION
2016-01-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DIGOXINPrescription
DIGOXIN 0.25MG/ML · INJECTABLE · INJECTION
Approval history
2016-01-10Labeling · Supplement 27 · standardAP
2016-01-10Labeling · Supplement 25 · standardAP
2000-12-22Labeling · Supplement 20AP
1998-11-25Manufacturing (CMC) · Supplement 19AP
1998-04-28Labeling · Supplement 18AP
1993-04-13Labeling · Supplement 17AP
1992-01-31Labeling · Supplement 16AP
1991-09-23Manufacturing (CMC) · Supplement 15AP
1991-09-23Manufacturing (CMC) · Supplement 11AP
1991-01-18Labeling · Supplement 14AP
1990-10-29Labeling · Supplement 13AP
1989-07-26Labeling · Supplement 12AP
1982-09-13Manufacturing (CMC) · Supplement 7AP
1975-10-24OriginalAP
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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