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FDA ANDA · ANDA071200

DISOPYRAMIDE PHOSPHATE

Sponsor: NESHER PHARMS

APPLICATION
ANDA071200
TYPE
ANDA
ORIGINAL APPROVAL
1987-12-15
LATEST ACTION
2002-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DISOPYRAMIDE PHOSPHATEDiscontinued
DISOPYRAMIDE PHOSPHATE EQ 150MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2002-06-12Manufacturing (CMC) · Supplement 19AP
2002-06-12Labeling · Supplement 23AP
2002-06-12Manufacturing (CMC) · Supplement 21AP
2002-06-12Manufacturing (CMC) · Supplement 18AP
2002-06-12Manufacturing (CMC) · Supplement 20AP
2000-10-26Manufacturing (CMC) · Supplement 16AP
2000-10-25Labeling · Supplement 17AP
1999-04-05Manufacturing (CMC) · Supplement 15AP
1998-10-06Manufacturing (CMC) · Supplement 13AP
1996-11-25Labeling · Supplement 14AP
1993-02-25Manufacturing (CMC) · Supplement 9AP
1993-01-14Labeling · Supplement 12AP
1992-10-07Labeling · Supplement 11AP
1992-04-30Labeling · Supplement 10AP
1991-12-09Manufacturing (CMC) · Supplement 5AP
1991-10-23Labeling · Supplement 8AP
1991-05-21Manufacturing (CMC) · Supplement 4AP
1990-02-02Labeling · Supplement 2AP
1990-01-29Manufacturing (CMC) · Supplement 3AP
1987-12-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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