← FDA DRUG APPROVALS

FDA NDA · NDA019574

THALITONE

chlorthalidone

Sponsor: CASPER PHARMA LLC

APPLICATION
NDA019574
TYPE
NDA
ORIGINAL APPROVAL
1988-12-20
LATEST ACTION
2019-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

THALITONE · ReferencePrescription
CHLORTHALIDONE 15MG · TABLET · ORAL
THALITONE · ReferenceDiscontinued
CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

2019-09-17Labeling · Supplement 17 · standard — Label ↗AP
2018-04-19Labeling · Supplement 16 · standard — Label ↗AP
2004-06-01Labeling · Supplement 10 · standard — Letter ↗AP
2001-06-21Manufacturing (CMC) · Supplement 11 · standardAP
2000-02-11Manufacturing (CMC) · Supplement 9 · standardAP
1999-03-16Manufacturing (CMC) · Supplement 8 · standardAP
1997-10-23Manufacturing (CMC) · Supplement 7 · standardAP
1995-10-26Manufacturing (CMC) · Supplement 6 · standardAP
1994-06-27Manufacturing (CMC) · Supplement 5 · standardAP
1994-04-08Labeling · Supplement 4 · standardAP
1993-06-26Labeling · Supplement 3 · standardAP
1992-10-15Labeling · Supplement 2AP
1992-02-12Manufacturing (CMC) · Supplement 1 · standardAP
1988-12-20Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →