APPLICATION
ANDA209808
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-22
LATEST ACTION
2024-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CLOBAZAMPrescription
CLOBAZAM 10MG · TABLET · ORAL
CLOBAZAMPrescription
CLOBAZAM 20MG · TABLET · ORAL
Approval history
2024-06-10Labeling · Supplement 3 · standardAP
2023-05-03Labeling · Supplement 2 · standardAP
2021-10-25Labeling · Supplement 1 · standardAP
2018-10-22UNKNOWN · 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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