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FDA ANDA · ANDA083862

QUINIDINE SULFATE

Sponsor: HIKMA

APPLICATION
ANDA083862
TYPE
ANDA
ORIGINAL APPROVAL
1976-09-02
LATEST ACTION
1991-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 200MG · TABLET · ORAL

Approval history

1991-01-07Manufacturing (CMC) · Supplement 15AP
1986-04-18Manufacturing (CMC) · Supplement 12AP
1984-11-20Manufacturing (CMC) · Supplement 10AP
1984-11-20Manufacturing (CMC) · Supplement 9AP
1984-02-01Manufacturing (CMC) · Supplement 8AP
1982-11-09Manufacturing (CMC) · Supplement 1AP
1982-04-08Manufacturing (CMC) · Supplement 6AP
1982-04-08Manufacturing (CMC) · Supplement 4AP
1976-09-02OriginalAP
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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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