APPLICATION
ANDA075468
TYPE
ANDA
ORIGINAL APPROVAL
2000-10-06
LATEST ACTION
2026-06-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.25MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET · ORAL
Approval history
2026-06-12Manufacturing (CMC) · Supplement 31 · unknownAP
2016-07-18Labeling · Supplement 19 · standardAP
2015-08-10Labeling · Supplement 18 · standardAP
2013-05-31Labeling · Supplement 17 · standardAP
2010-07-06Labeling · Supplement 16AP
2003-08-04Labeling · Supplement 4AP
2002-01-08Labeling · Supplement 3AP
2002-01-08Manufacturing (CMC) · Supplement 1AP
2002-01-08Manufacturing (CMC) · Supplement 2AP
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.
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