APPLICATION
ANDA077194
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-10
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 14 · standardAP
2022-12-14Labeling · Supplement 13 · standardAP
2021-02-05Labeling · Supplement 10 · standardAP
2021-01-25Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 7 · standardAP
2013-01-28Labeling · Supplement 5AP
2013-01-28Labeling · Supplement 3AP
2010-06-27Labeling · Supplement 1AP
2005-08-10OriginalAP
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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