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FDA ANDA · ANDA085140

QUINIDINE SULFATE

Sponsor: WATSON LABS

APPLICATION
ANDA085140
TYPE
ANDA
ORIGINAL APPROVAL
1976-12-13
LATEST ACTION
1998-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 200MG · TABLET · ORAL

Approval history

1998-07-17Manufacturing (CMC) · Supplement 40AP
1997-05-23Manufacturing (CMC) · Supplement 39AP
1996-05-16Labeling · Supplement 38AP
1995-07-11Manufacturing (CMC) · Supplement 37AP
1991-07-31Labeling · Supplement 36AP
1988-02-25Manufacturing (CMC) · Supplement 33AP
1988-02-25Manufacturing (CMC) · Supplement 34AP
1988-02-25Manufacturing (CMC) · Supplement 32AP
1987-12-21Manufacturing (CMC) · Supplement 35AP
1987-12-21Manufacturing (CMC) · Supplement 31AP
1987-12-21Manufacturing (CMC) · Supplement 30AP
1987-09-28Manufacturing (CMC) · Supplement 29AP
1987-09-28Manufacturing (CMC) · Supplement 28AP
1986-10-21Manufacturing (CMC) · Supplement 27AP
1986-09-04Manufacturing (CMC) · Supplement 25AP
1986-09-04Manufacturing (CMC) · Supplement 23AP
1986-09-04Manufacturing (CMC) · Supplement 24AP
1986-03-27Manufacturing (CMC) · Supplement 22AP
1976-12-13OriginalAP
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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