APPLICATION
NDA011870
TYPE
NDA
ORIGINAL APPROVAL
1961-10-06
LATEST ACTION
2009-06-10
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
DIURIL · ReferenceDiscontinued
CHLOROTHIAZIDE 250MG/5ML · SUSPENSION · ORAL
Approval history
2009-04-02Manufacturing (CMC) · Supplement 41AP
2002-09-26Manufacturing (CMC) · Supplement 35 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 33 · standardAP
2000-02-25Manufacturing (CMC) · Supplement 32 · standardAP
1998-12-09Labeling · Supplement 31 · standardAP
1995-05-23Labeling · Supplement 30 · standardAP
1994-02-16Labeling · Supplement 29AP
1993-03-02Labeling · Supplement 27AP
1987-05-08Labeling · Supplement 19AP
1986-01-13Labeling · Supplement 23AP
1985-11-04Labeling · Supplement 22AP
1984-08-28Labeling · Supplement 21AP
1984-03-06Labeling · Supplement 20AP
1981-01-13Labeling · Supplement 18AP
1979-10-31Labeling · Supplement 14AP
1979-10-31Labeling · Supplement 17AP
1979-10-31Labeling · Supplement 15AP
1979-07-13Labeling · Supplement 16AP
1978-07-31Labeling · Supplement 13AP
1975-03-27REMS · Supplement 6 · standardAP
1961-10-06Type 3 - New Dosage Form · 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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