APPLICATION
ANDA211033
TYPE
ANDA
ORIGINAL APPROVAL
2019-06-28
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 11 · standardAP
2021-02-05Labeling · Supplement 5 · standardAP
2019-06-28UNKNOWN · Original · standardAP
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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