APPLICATION
NDA013636
TYPE
NDA
ORIGINAL APPROVAL
1963-10-15
LATEST ACTION
1992-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RENESE-RDiscontinued
POLYTHIAZIDE 2MG, RESERPINE 0.25MG · TABLET · ORAL
Approval history
1992-06-26Manufacturing (CMC) · Supplement 20 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 19 · standardAP
1984-02-07Manufacturing (CMC) · Supplement 18 · standardAP
1983-08-09Labeling · Supplement 16AP
1981-02-13Manufacturing (CMC) · Supplement 15 · standardAP
1975-04-22Labeling · Supplement 7AP
1963-10-15Type 4 - New Combination · Original · standardAP
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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