← FDA DRUG APPROVALS

FDA ANDA · ANDA086831

CHLORTHALIDONE

Sponsor: MYLAN

APPLICATION
ANDA086831
TYPE
ANDA
ORIGINAL APPROVAL
1981-02-26
LATEST ACTION
2002-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CHLORTHALIDONE · ReferencePrescription
CHLORTHALIDONE 50MG · TABLET · ORAL
CHLORTHALIDONE · ReferencePrescription
CHLORTHALIDONE 25MG · TABLET · ORAL

Approval history

2002-08-22Manufacturing (CMC) · Supplement 31AP
1999-12-10Manufacturing (CMC) · Supplement 30AP
1998-02-25Manufacturing (CMC) · Supplement 29AP
1998-02-05Manufacturing (CMC) · Supplement 28AP
1993-12-20Manufacturing (CMC) · Supplement 27AP
1993-06-21Labeling · Supplement 26 — Label ↗AP
1992-01-13Labeling · Supplement 24AP
1991-09-20Labeling · Supplement 23AP
1990-01-31Manufacturing (CMC) · Supplement 22AP
1989-12-19Labeling · Supplement 21AP
1988-03-29Manufacturing (CMC) · Supplement 20AP
1987-10-19Manufacturing (CMC) · Supplement 19AP
1985-03-15Manufacturing (CMC) · Supplement 16AP
1984-08-24Manufacturing (CMC) · Supplement 15AP
1982-06-24Manufacturing (CMC) · Supplement 1AP
1981-02-26OriginalAP
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 →