APPLICATION
ANDA084386
TYPE
ANDA
ORIGINAL APPROVAL
1976-07-12
LATEST ACTION
1998-08-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DIGOXINDiscontinued
DIGOXIN 0.25MG/ML · INJECTABLE · INJECTION
Approval history
1998-08-25Labeling · Supplement 12AP
1993-03-10Labeling · Supplement 11AP
1991-02-15Labeling · Supplement 9AP
1987-03-12Manufacturing (CMC) · Supplement 6AP
1984-11-30Manufacturing (CMC) · Supplement 4AP
1976-07-12OriginalAP
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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