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FDA ANDA · ANDA089219

PROCAINAMIDE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA089219
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-01
LATEST ACTION
1994-01-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 375MG · CAPSULE · ORAL
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · CAPSULE · ORAL
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG · CAPSULE · ORAL

Approval history

1994-01-24Manufacturing (CMC) · Supplement 6AP
1991-02-14Labeling · Supplement 5AP
1988-10-20Labeling · Supplement 4AP
1987-07-14Manufacturing (CMC) · Supplement 2AP
1987-07-14Manufacturing (CMC) · Supplement 3AP
1987-07-14Manufacturing (CMC) · Supplement 1AP
1986-07-01OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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