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FDA ANDA · ANDA084696

PROCAINAMIDE HYDROCHLORIDE

Sponsor: LANNETT

APPLICATION
ANDA084696
TYPE
ANDA
ORIGINAL APPROVAL
1977-05-11
LATEST ACTION
1982-05-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · CAPSULE · ORAL

Approval history

1982-05-18Manufacturing (CMC) · Supplement 12AP
1982-05-18Manufacturing (CMC) · Supplement 13AP
1977-05-11OriginalAP
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