APPLICATION
NDA012489
TYPE
NDA
ORIGINAL APPROVAL
1960-10-14
LATEST ACTION
1994-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EXNADiscontinued
BENZTHIAZIDE 50MG · TABLET · ORAL
Approval history
1994-12-01Labeling · Supplement 22 · standardAP
1986-04-11Labeling · Supplement 18 · standardAP
1983-09-13Manufacturing (CMC) · Supplement 21 · standardAP
1982-12-10Manufacturing (CMC) · Supplement 20 · standardAP
1982-07-15Labeling · Supplement 19 · standardAP
1982-04-12Manufacturing (CMC) · Supplement 17 · standardAP
1981-02-17Manufacturing (CMC) · Supplement 16 · standardAP
1981-02-13Labeling · Supplement 15 · standardAP
1981-01-27Manufacturing (CMC) · Supplement 14 · standardAP
1979-04-18Manufacturing (CMC) · Supplement 13 · standardAP
1979-04-18Manufacturing (CMC) · Supplement 11 · standardAP
1979-04-18Manufacturing (CMC) · Supplement 12 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 9 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 10 · standardAP
1977-04-08Manufacturing (CMC) · Supplement 8 · standardAP
1976-06-02Manufacturing (CMC) · Supplement 7 · standardAP
1976-04-02Manufacturing (CMC) · Supplement 6 · standardAP
1975-03-25Labeling · Supplement 4 · standardAP
1960-10-14Type 5 - New Formulation or New Manufacturer · 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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