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FDA ANDA · ANDA088826

CHLORPROPAMIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA088826
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-26
LATEST ACTION
1991-12-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLORPROPAMIDEDiscontinued
CHLORPROPAMIDE 250MG · TABLET · ORAL

Approval history

1991-12-26Labeling · Supplement 14AP
1991-11-27Labeling · Supplement 13AP
1991-06-13Manufacturing (CMC) · Supplement 12AP
1991-05-31Manufacturing (CMC) · Supplement 10AP
1991-01-28Manufacturing (CMC) · Supplement 11AP
1990-06-29Manufacturing (CMC) · Supplement 9AP
1988-06-22Labeling · Supplement 8AP
1988-04-25Manufacturing (CMC) · Supplement 6AP
1988-04-25Manufacturing (CMC) · Supplement 7AP
1987-04-28Manufacturing (CMC) · Supplement 4AP
1986-10-29Manufacturing (CMC) · Supplement 2AP
1985-07-19Manufacturing (CMC) · Supplement 1AP
1984-09-26OriginalAP
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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