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FDA ANDA · ANDA070173

DISOPYRAMIDE PHOSPHATE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA070173
TYPE
ANDA
ORIGINAL APPROVAL
1985-05-31
LATEST ACTION
2001-05-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DISOPYRAMIDE PHOSPHATEPrescription
DISOPYRAMIDE PHOSPHATE EQ 100MG BASE · CAPSULE · ORAL
DISOPYRAMIDE PHOSPHATEPrescription
DISOPYRAMIDE PHOSPHATE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2001-05-07Manufacturing (CMC) · Supplement 26AP
2001-04-25Manufacturing (CMC) · Supplement 27AP
2001-01-11Labeling · Supplement 25AP
2000-09-12Labeling · Supplement 23AP
2000-09-12Manufacturing (CMC) · Supplement 24AP
1999-07-26Labeling · Supplement 22AP
1999-03-03Manufacturing (CMC) · Supplement 20AP
1998-02-17Manufacturing (CMC) · Supplement 18AP
1997-11-14Manufacturing (CMC) · Supplement 19AP
1996-10-23Labeling · Supplement 17AP
1992-11-24Labeling · Supplement 16AP
1991-10-02Labeling · Supplement 15AP
1991-05-31Manufacturing (CMC) · Supplement 13AP
1991-01-28Manufacturing (CMC) · Supplement 14AP
1990-06-29Manufacturing (CMC) · Supplement 12AP
1988-07-12Manufacturing (CMC) · Supplement 9AP
1988-07-12Manufacturing (CMC) · Supplement 11AP
1988-07-12Manufacturing (CMC) · Supplement 10AP
1986-04-16Manufacturing (CMC) · Supplement 5AP
1985-10-25Manufacturing (CMC) · Supplement 3AP
1985-07-24Manufacturing (CMC) · Supplement 1AP
1985-07-24Manufacturing (CMC) · Supplement 2AP
1985-05-31OriginalAP
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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