APPLICATION
NDA012359
TYPE
NDA
ORIGINAL APPROVAL
1960-06-20
LATEST ACTION
1996-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SALUTENSINDiscontinued
HYDROFLUMETHIAZIDE 50MG, RESERPINE 0.125MG · TABLET · ORAL
SALUTENSIN-DEMIDiscontinued
HYDROFLUMETHIAZIDE 25MG, RESERPINE 0.125MG · TABLET · ORAL
Approval history
1996-06-24Manufacturing (CMC) · Supplement 32 · standardAP
1992-10-07Manufacturing (CMC) · Supplement 31 · standardAP
1990-07-09Manufacturing (CMC) · Supplement 30 · standardAP
1988-06-22Labeling · Supplement 29 · standardAP
1986-10-24Manufacturing (CMC) · Supplement 28 · standardAP
1986-06-27Manufacturing (CMC) · Supplement 27 · standardAP
1985-08-01Manufacturing (CMC) · Supplement 26 · standardAP
1985-07-29Labeling · Supplement 18 · standardAP
1985-07-29Labeling · Supplement 25 · standardAP
1984-06-08Manufacturing (CMC) · Supplement 24 · standardAP
1984-05-10Manufacturing (CMC) · Supplement 22 · standardAP
1983-08-23Labeling · Supplement 23 · standardAP
1982-06-10Manufacturing (CMC) · Supplement 17 · standardAP
1982-03-03Manufacturing (CMC) · Supplement 20 · standardAP
1982-03-03Manufacturing (CMC) · Supplement 21 · standardAP
1981-08-03Labeling · Supplement 19 · standardAP
1980-10-03Manufacturing (CMC) · Supplement 14 · standardAP
1980-10-03Manufacturing (CMC) · Supplement 15 · standardAP
1979-07-31Labeling · Supplement 16 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 9 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 12 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 10 · standardAP
1978-05-15Labeling · Supplement 13 · standardAP
1978-04-27Manufacturing (CMC) · Supplement 11 · standardAP
1977-12-13REMS · Supplement 5 · standardAP
1977-06-23Manufacturing (CMC) · Supplement 3 · standardAP
1977-06-23Labeling · Supplement 6 · standardAP
1960-06-20Type 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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