APPLICATION
ANDA077171
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-03
LATEST ACTION
2023-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.25MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET, ORALLY DISINTEGRATING · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.125MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-01-17Labeling · Supplement 19 · standardAP
2021-02-05Labeling · Supplement 17 · standardAP
2021-01-22Labeling · Supplement 13 · standardAP
2016-12-16Labeling · Supplement 11 · standardAP
2013-07-26Labeling · Supplement 8AP
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.