← FDA DRUG APPROVALS

FDA ANDA · ANDA071511

CLORAZEPATE DIPOTASSIUM

Sponsor: NATCO PHARMA USA

APPLICATION
ANDA071511
TYPE
ANDA
ORIGINAL APPROVAL
1987-10-19
LATEST ACTION
2025-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CLORAZEPATE DIPOTASSIUMDiscontinued
CLORAZEPATE DIPOTASSIUM 15MG · CAPSULE · ORAL

Approval history

2025-08-21Labeling · Supplement 5 · standardAP
2025-08-21Labeling · Supplement 3 · standardAP
2016-12-16Labeling · Supplement 1 · standardAP
2016-12-16Labeling · Supplement 2 · standardAP
1987-10-19OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →