APPLICATION
ANDA215566
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-14
LATEST ACTION
2024-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLORAZEPATE DIPOTASSIUMPrescription
CLORAZEPATE DIPOTASSIUM 15MG · TABLET · ORAL
CLORAZEPATE DIPOTASSIUMPrescription
CLORAZEPATE DIPOTASSIUM 3.75MG · TABLET · ORAL
CLORAZEPATE DIPOTASSIUMPrescription
CLORAZEPATE DIPOTASSIUM 7.5MG · TABLET · ORAL
Approval history
2024-01-17Labeling · Supplement 1 · standardAP
2022-06-14UNKNOWN · 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.
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.