← FDA DRUG APPROVALS

FDA ANDA · ANDA216988

CLONAZEPAM

Sponsor: RUBICON RESEARCH

APPLICATION
ANDA216988
TYPE
ANDA
ORIGINAL APPROVAL
2026-05-21
LATEST ACTION
2026-05-21
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.125MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.25MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-05-21UNKNOWN · Original · standardLabelAP
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 →