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FDA ANDA · ANDA088072

QUINIDINE SULFATE

quinidine sulfate tablet

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA088072
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-26
LATEST ACTION
2022-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

QUINIDINE SULFATEPrescription
QUINIDINE SULFATE 300MG · TABLET · ORAL
QUINIDINE SULFATEPrescription
QUINIDINE SULFATE 200MG · TABLET · ORAL

Approval history

2022-02-10Manufacturing (CMC) · Supplement 18 · unknownAP
2000-02-02Manufacturing (CMC) · Supplement 13AP
1999-02-18Labeling · Supplement 12AP
1996-09-03Labeling · Supplement 11AP
1994-11-08Manufacturing (CMC) · Supplement 8AP
1994-11-08Manufacturing (CMC) · Supplement 9AP
1992-10-29Labeling · Supplement 10AP
1989-06-16Labeling · Supplement 7AP
1989-02-07Manufacturing (CMC) · Supplement 6AP
1985-05-13Manufacturing (CMC) · Supplement 2AP
1983-09-26OriginalAP
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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