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FDA ANDA · ANDA088557

CHLOROTHIAZIDE AND RESERPINE

Sponsor: HIKMA

APPLICATION
ANDA088557
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-22
LATEST ACTION
1990-09-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHLOROTHIAZIDE AND RESERPINEDiscontinued
CHLOROTHIAZIDE 250MG, RESERPINE 0.125MG · TABLET · ORAL

Approval history

1990-09-20Manufacturing (CMC) · Supplement 9AP
1989-03-17Labeling · Supplement 11AP
1989-03-17Labeling · Supplement 7AP
1983-12-22OriginalAP
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