APPLICATION
NDA012845
TYPE
NDA
ORIGINAL APPROVAL
1961-09-26
LATEST ACTION
1998-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RENESEDiscontinued
POLYTHIAZIDE 2MG · TABLET · ORAL
RENESEDiscontinued
POLYTHIAZIDE 4MG · TABLET · ORAL
RENESEDiscontinued
POLYTHIAZIDE 1MG · TABLET · ORAL
Approval history
1998-06-24Labeling · Supplement 26 · standardAP
1992-06-26Manufacturing (CMC) · Supplement 25 · standardAP
1984-03-20Manufacturing (CMC) · Supplement 24 · standardAP
1984-02-07Manufacturing (CMC) · Supplement 23 · standardAP
1981-02-05Manufacturing (CMC) · Supplement 21 · standardAP
1979-04-06Manufacturing (CMC) · Supplement 20 · standardAP
1978-05-22Manufacturing (CMC) · Supplement 19 · standardAP
1977-10-06Manufacturing (CMC) · Supplement 18 · standardAP
1976-09-28Manufacturing (CMC) · Supplement 16 · standardAP
1976-09-28Labeling · Supplement 17AP
1975-10-28Manufacturing (CMC) · Supplement 14 · standardAP
1975-06-05Manufacturing (CMC) · Supplement 13 · standardAP
1975-05-07Labeling · Supplement 12AP
1961-09-26Type 1 - New Molecular Entity · 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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