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FDA ANDA · ANDA070102

DISOPYRAMIDE PHOSPHATE

Sponsor: TEVA

APPLICATION
ANDA070102
TYPE
ANDA
ORIGINAL APPROVAL
1985-02-22
LATEST ACTION
2015-04-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DISOPYRAMIDE PHOSPHATEPrescription
DISOPYRAMIDE PHOSPHATE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2015-04-29Labeling · Supplement 51 · standardAP
2007-02-08Manufacturing (CMC) · Supplement 49AP
2001-02-08Labeling · Supplement 46AP
2000-11-01Labeling · Supplement 45AP
2000-10-31Manufacturing (CMC) · Supplement 41AP
2000-10-31Manufacturing (CMC) · Supplement 42AP
2000-10-31Manufacturing (CMC) · Supplement 40AP
2000-07-07Manufacturing (CMC) · Supplement 44AP
2000-05-16Manufacturing (CMC) · Supplement 43AP
1999-04-30Labeling · Supplement 39AP
1997-12-10Manufacturing (CMC) · Supplement 38AP
1997-06-18Manufacturing (CMC) · Supplement 36AP
1997-04-07Labeling · Supplement 37AP
1996-07-31Manufacturing (CMC) · Supplement 31AP
1996-07-12Manufacturing (CMC) · Supplement 32AP
1995-03-08Manufacturing (CMC) · Supplement 34AP
1995-01-23Manufacturing (CMC) · Supplement 33AP
1992-08-11Labeling · Supplement 30AP
1992-06-11Labeling · Supplement 29AP
1991-12-19Labeling · Supplement 28AP
1991-05-30Labeling · Supplement 27AP
1990-10-03Labeling · Supplement 26AP
1988-07-06Manufacturing (CMC) · Supplement 25AP
1987-10-30Manufacturing (CMC) · Supplement 23AP
1986-10-10Manufacturing (CMC) · Supplement 17AP
1986-10-10Manufacturing (CMC) · Supplement 22AP
1986-04-14Manufacturing (CMC) · Supplement 19AP
1986-04-14Manufacturing (CMC) · Supplement 18AP
1985-08-15Manufacturing (CMC) · Supplement 14AP
1985-08-15Manufacturing (CMC) · Supplement 12AP
1985-05-20Manufacturing (CMC) · Supplement 8AP
1985-05-20Manufacturing (CMC) · Supplement 4AP
1985-05-20Manufacturing (CMC) · Supplement 2AP
1985-05-20Manufacturing (CMC) · Supplement 7AP
1985-05-20Manufacturing (CMC) · Supplement 5AP
1985-05-20Manufacturing (CMC) · Supplement 3AP
1985-02-22OriginalAP
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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