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FDA ANDA · ANDA085632

QUINIDINE SULFATE

Sponsor: CYCLE

APPLICATION
ANDA085632
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-02
LATEST ACTION
1996-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 300MG · TABLET · ORAL

Approval history

1996-08-28Manufacturing (CMC) · Supplement 15AP
1996-07-15Labeling · Supplement 16AP
1991-05-09Labeling · Supplement 13AP
1991-05-09Labeling · Supplement 14AP
1990-06-06Labeling · Supplement 11AP
1989-09-12Labeling · Supplement 10AP
1989-01-24Manufacturing (CMC) · Supplement 7AP
1989-01-24Manufacturing (CMC) · Supplement 8AP
1988-12-30Bioequivalence · Supplement 1AP
1977-08-02OriginalAP
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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