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
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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