APPLICATION
ANDA077856
TYPE
ANDA
ORIGINAL APPROVAL
2006-06-28
LATEST ACTION
2016-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLONAZEPAMPrescription
CLONAZEPAM 1MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 2MG · TABLET · ORAL
CLONAZEPAMPrescription
CLONAZEPAM 0.5MG · TABLET · ORAL
Approval history
2016-07-18Labeling · Supplement 18 · standardAP
2016-02-10Labeling · Supplement 11 · standardAP
2012-06-20REMS · Supplement 8AP
2011-09-15Labeling · Supplement 5AP
2009-10-21Labeling · Supplement 3AP
2007-07-09Labeling · Supplement 2AP
2007-05-01Labeling · Supplement 1AP
2006-06-28OriginalAP
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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