APPLICATION
ANDA084280
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-07
LATEST ACTION
1998-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · CAPSULE · ORAL
Approval history
1998-07-29Labeling · Supplement 47AP
1992-02-24Labeling · Supplement 46AP
1991-08-07Manufacturing (CMC) · Supplement 43AP
1991-01-28Manufacturing (CMC) · Supplement 44AP
1988-11-01Labeling · Supplement 45AP
1988-11-01Labeling · Supplement 40AP
1988-03-14Manufacturing (CMC) · Supplement 39AP
1988-03-14Manufacturing (CMC) · Supplement 38AP
1985-12-18Manufacturing (CMC) · Supplement 35AP
1985-12-18Manufacturing (CMC) · Supplement 33AP
1985-12-18Manufacturing (CMC) · Supplement 34AP
1985-06-03Manufacturing (CMC) · Supplement 31AP
1985-06-03Manufacturing (CMC) · Supplement 32AP
1983-12-06Manufacturing (CMC) · Supplement 30AP
1983-01-24Manufacturing (CMC) · Supplement 29AP
1977-06-07OriginalAP
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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