APPLICATION
NDA011145
TYPE
NDA
ORIGINAL APPROVAL
1958-09-04
LATEST ACTION
2013-03-20
ROUTE
ORAL, INJECTION
DOSAGE FORM
TABLET, INJECTABLE
MARKETING STATUS
Discontinued
Products
DIURIL · ReferenceDiscontinued
CHLOROTHIAZIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DIURIL · ReferenceDiscontinued
CHLOROTHIAZIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
DIURIL · ReferenceDiscontinued
CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2013-03-20Manufacturing (CMC) · Supplement 98 · priorityAP
2002-11-08Manufacturing (CMC) · Supplement 89 · priorityAP
1999-09-08Manufacturing (CMC) · Supplement 88 · priorityAP
1998-12-09Labeling · Supplement 85 · standardAP
1997-09-05Manufacturing (CMC) · Supplement 87 · priorityAP
1997-05-05Manufacturing (CMC) · Supplement 86 · priorityAP
1995-11-29Manufacturing (CMC) · Supplement 84 · priorityAP
1995-05-23Labeling · Supplement 83 · standardAP
1995-05-23Labeling · Supplement 82 · standardAP
1994-03-31Labeling · Supplement 80 · standardAP
1994-03-16Manufacturing (CMC) · Supplement 81 · priorityAP
1994-02-16Labeling · Supplement 78AP
1993-03-02Labeling · Supplement 73AP
1993-03-02Labeling · Supplement 74AP
1993-03-02Labeling · Supplement 79AP
1989-05-30Manufacturing (CMC) · Supplement 75 · priorityAP
1987-05-08Labeling · Supplement 48AP
1986-12-08Manufacturing (CMC) · Supplement 68 · priorityAP
1986-01-14Labeling · Supplement 64AP
1986-01-13Labeling · Supplement 63AP
1985-11-04Labeling · Supplement 62AP
1985-08-27Manufacturing (CMC) · Supplement 60 · priorityAP
1984-10-11Manufacturing (CMC) · Supplement 59 · priorityAP
1984-10-11Manufacturing (CMC) · Supplement 61 · priorityAP
1984-09-24Labeling · Supplement 58AP
1984-08-30Manufacturing (CMC) · Supplement 56 · priorityAP
1984-08-28Labeling · Supplement 57AP
1984-03-06Labeling · Supplement 55AP
1984-03-06Labeling · Supplement 54AP
1983-03-01Manufacturing (CMC) · Supplement 53 · priorityAP
1982-04-19Manufacturing (CMC) · Supplement 52 · priorityAP
1981-11-03Manufacturing (CMC) · Supplement 50 · priorityAP
1981-07-14Manufacturing (CMC) · Supplement 51 · priorityAP
1981-06-17Manufacturing (CMC) · Supplement 49 · priorityAP
1981-01-13Labeling · Supplement 45AP
1981-01-13Labeling · Supplement 46AP
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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