APPLICATION
ANDA210746
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-10
LATEST ACTION
2024-07-15
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
CLOBAZAMDiscontinued
CLOBAZAM 2.5MG/ML · SUSPENSION · ORAL
Approval history
2024-07-15Labeling · Supplement 10 · standardAP
2023-05-22Labeling · Supplement 7 · standardAP
2022-02-11Labeling · Supplement 1 · standardAP
2019-07-10UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.