APPLICATION
ANDA070351
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-17
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DISOPYRAMIDE PHOSPHATEDiscontinued
DISOPYRAMIDE PHOSPHATE EQ 100MG BASE · CAPSULE · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 24AP
1994-12-23Manufacturing (CMC) · Supplement 23AP
1994-10-11Manufacturing (CMC) · Supplement 22AP
1992-10-15Labeling · Supplement 21AP
1992-04-03Manufacturing (CMC) · Supplement 18AP
1992-04-03Manufacturing (CMC) · Supplement 20AP
1991-11-21Labeling · Supplement 17AP
1991-09-30Labeling · Supplement 16AP
1990-08-22Labeling · Supplement 15AP
1987-10-09Manufacturing (CMC) · Supplement 12AP
1987-03-30Manufacturing (CMC) · Supplement 11AP
1986-05-22Manufacturing (CMC) · Supplement 3AP
1986-04-08Manufacturing (CMC) · Supplement 5AP
1986-04-08Manufacturing (CMC) · Supplement 1AP
1986-04-08Manufacturing (CMC) · Supplement 6AP
1986-04-08Manufacturing (CMC) · Supplement 2AP
1985-12-17OriginalAP
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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