APPLICATION
ANDA211259
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-22
LATEST ACTION
2023-05-01
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
CLOBAZAMDiscontinued
CLOBAZAM 2.5MG/ML · SUSPENSION · ORAL
Approval history
2023-05-01Labeling · Supplement 4 · standardAP
2022-02-11Labeling · Supplement 2 · standardAP
2019-07-19Manufacturing (CMC) · Supplement 1AP
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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