APPLICATION
NDA016042
TYPE
NDA
ORIGINAL APPROVAL
1965-12-02
LATEST ACTION
2020-08-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DYAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
DYAZIDE · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 25MG, TRIAMTERENE 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2001-02-23Labeling · Supplement 69 · standardAP
2000-12-20Manufacturing (CMC) · Supplement 70 · standardAP
1999-03-16Manufacturing (CMC) · Supplement 68 · standardAP
1998-08-31Manufacturing (CMC) · Supplement 67 · standardAP
1994-12-01Labeling · Supplement 66 · standardAP
1994-05-20Manufacturing (CMC) · Supplement 65 · standardAP
1994-03-03Efficacy · Supplement 55 · unknownAP
1994-03-03Labeling · Supplement 64 · standardAP
1992-05-01Manufacturing (CMC) · Supplement 62 · standardAP
1991-12-02Manufacturing (CMC) · Supplement 61 · standardAP
1988-04-26Labeling · Supplement 47AP
1988-02-23Manufacturing (CMC) · Supplement 59 · standardAP
1986-07-29Labeling · Supplement 57AP
1985-03-07Labeling · Supplement 56AP
1985-01-03Labeling · Supplement 52AP
1983-05-13Manufacturing (CMC) · Supplement 54 · standardAP
1982-10-08Labeling · Supplement 51AP
1982-08-25Labeling · Supplement 49AP
1982-02-23Labeling · Supplement 46AP
1981-10-30Labeling · Supplement 48AP
1981-02-02Manufacturing (CMC) · Supplement 40 · standardAP
1981-01-27Labeling · Supplement 44AP
1980-07-14Labeling · Supplement 45AP
1980-01-14Labeling · Supplement 43AP
1979-12-06Labeling · Supplement 41AP
1979-09-18Labeling · Supplement 38AP
1979-09-18Labeling · Supplement 39AP
1979-09-18Labeling · Supplement 37AP
1978-02-22Labeling · Supplement 32AP
1978-02-22Labeling · Supplement 30AP
1978-02-22Labeling · Supplement 33AP
1978-02-22Labeling · Supplement 31AP
1978-01-19Manufacturing (CMC) · Supplement 36 · standardAP
1978-01-19Manufacturing (CMC) · Supplement 34 · standardAP
1978-01-19Manufacturing (CMC) · Supplement 35 · standardAP
1977-06-14Manufacturing (CMC) · Supplement 29 · 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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