APPLICATION
ANDA087706
TYPE
ANDA
ORIGINAL APPROVAL
1981-09-16
LATEST ACTION
1994-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLORTHALIDONEDiscontinued
CHLORTHALIDONE 25MG · TABLET · ORAL
Approval history
1994-09-14Manufacturing (CMC) · Supplement 19AP
1994-03-04Labeling · Supplement 17AP
1991-05-31Manufacturing (CMC) · Supplement 15AP
1991-01-28Manufacturing (CMC) · Supplement 16AP
1990-06-29Manufacturing (CMC) · Supplement 14AP
1989-03-24Labeling · Supplement 13AP
1988-04-13Manufacturing (CMC) · Supplement 11AP
1988-04-13Manufacturing (CMC) · Supplement 9AP
1988-04-13Manufacturing (CMC) · Supplement 10AP
1985-08-29Manufacturing (CMC) · Supplement 6AP
1985-03-11Manufacturing (CMC) · Supplement 5AP
1984-06-29Manufacturing (CMC) · Supplement 4AP
1984-01-30Manufacturing (CMC) · Supplement 3AP
1983-02-25Manufacturing (CMC) · Supplement 1AP
1981-09-16OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.