APPLICATION
ANDA084714
TYPE
ANDA
ORIGINAL APPROVAL
1979-11-20
LATEST ACTION
1992-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRO-RESERPDiscontinued
HYDROCHLOROTHIAZIDE 50MG, RESERPINE 0.125MG · TABLET · ORAL
Approval history
1992-03-19Labeling · Supplement 15AP
1991-12-31Labeling · Supplement 14AP
1989-11-06Labeling · Supplement 12AP
1983-02-11Manufacturing (CMC) · Supplement 8AP
1982-06-29Manufacturing (CMC) · Supplement 3AP
1982-06-29Manufacturing (CMC) · Supplement 2AP
1981-11-02Manufacturing (CMC) · Supplement 6AP
1979-11-20OriginalAP
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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