APPLICATION
ANDA213039
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-06
LATEST ACTION
2025-02-19
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
CLOBAZAMPrescription
CLOBAZAM 2.5MG/ML · SUSPENSION · ORAL
Approval history
2025-02-19Labeling · Supplement 5 · standardAP
2023-04-26Labeling · Supplement 4 · standardAP
2021-05-06UNKNOWN · 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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