APPLICATION
NDA011793
TYPE
NDA
ORIGINAL APPROVAL
1959-02-12
LATEST ACTION
2002-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ESIDRIXDiscontinued
HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
ESIDRIXDiscontinued
HYDROCHLOROTHIAZIDE 100MG · TABLET · ORAL
ESIDRIXDiscontinued
HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2002-04-29Manufacturing (CMC) · Supplement 70 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 69 · standardAP
1997-07-21Manufacturing (CMC) · Supplement 68 · standardAP
1996-06-20Manufacturing (CMC) · Supplement 67 · standardAP
1996-02-27Manufacturing (CMC) · Supplement 66 · standardAP
1995-07-31Manufacturing (CMC) · Supplement 65 · standardAP
1994-12-01Labeling · Supplement 64 · standardAP
1993-03-10Labeling · Supplement 62 · standardAP
1992-07-30Labeling · Supplement 60AP
1991-06-05Labeling · Supplement 61AP
1990-11-09Manufacturing (CMC) · Supplement 59 · standardAP
1988-09-23Labeling · Supplement 58AP
1986-10-02Labeling · Supplement 57AP
1986-04-10Labeling · Supplement 51AP
1985-03-19Manufacturing (CMC) · Supplement 56 · standardAP
1982-12-08Manufacturing (CMC) · Supplement 55 · standardAP
1982-08-23Manufacturing (CMC) · Supplement 54 · standardAP
1982-06-04Manufacturing (CMC) · Supplement 53 · standardAP
1981-02-02Manufacturing (CMC) · Supplement 50 · standardAP
1980-01-30Manufacturing (CMC) · Supplement 49 · standardAP
1980-01-17Manufacturing (CMC) · Supplement 48 · standardAP
1979-06-29Manufacturing (CMC) · Supplement 47 · standardAP
1979-06-29Manufacturing (CMC) · Supplement 45 · standardAP
1979-06-29Manufacturing (CMC) · Supplement 46 · standardAP
1978-02-22Labeling · Supplement 41AP
1978-01-10Manufacturing (CMC) · Supplement 44 · standardAP
1977-06-16Manufacturing (CMC) · Supplement 43 · standardAP
1977-04-12Manufacturing (CMC) · Supplement 42 · standardAP
1977-02-09Labeling · Supplement 38AP
1977-02-09Labeling · Supplement 40AP
1976-08-31Manufacturing (CMC) · Supplement 39 · standardAP
1976-08-18Manufacturing (CMC) · Supplement 37 · standardAP
1976-05-20Manufacturing (CMC) · Supplement 36 · standardAP
1976-03-24Manufacturing (CMC) · Supplement 35 · standardAP
1976-03-24Manufacturing (CMC) · Supplement 33 · standardAP
1975-10-09Labeling · Supplement 34AP
1975-07-02Manufacturing (CMC) · Supplement 32 · standardAP
1975-04-02Manufacturing (CMC) · Supplement 29 · standardAP
1975-04-02Manufacturing (CMC) · Supplement 30 · standardAP
1959-02-12Type 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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