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FDA ANDA · ANDA083287

PROCAINAMIDE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA083287
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-03
LATEST ACTION
1998-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG · CAPSULE · ORAL

Approval history

1998-07-29Labeling · Supplement 50AP
1992-02-24Labeling · Supplement 49AP
1991-08-07Manufacturing (CMC) · Supplement 47AP
1991-01-28Manufacturing (CMC) · Supplement 48AP
1990-06-29Manufacturing (CMC) · Supplement 46AP
1988-11-01Labeling · Supplement 45AP
1987-12-14Manufacturing (CMC) · Supplement 44AP
1987-11-19Manufacturing (CMC) · Supplement 42AP
1987-11-19Manufacturing (CMC) · Supplement 43AP
1987-11-19Manufacturing (CMC) · Supplement 41AP
1985-12-18Manufacturing (CMC) · Supplement 38AP
1985-12-18Manufacturing (CMC) · Supplement 39AP
1985-12-18Manufacturing (CMC) · Supplement 37AP
1985-06-03Manufacturing (CMC) · Supplement 36AP
1985-06-03Manufacturing (CMC) · Supplement 35AP
1983-12-08Manufacturing (CMC) · Supplement 34AP
1983-02-28Manufacturing (CMC) · Supplement 33AP
1977-06-03OriginalAP
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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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