APPLICATION
ANDA219248
TYPE
ANDA
DOSAGE FORM
CAPSULE
MARKETING STATUS
None (Tentative Approval)
Products
LUMATEPERONE TOSYLATENone (Tentative Approval)
LUMATEPERONE TOSYLATE 42MG · CAPSULE
LUMATEPERONE TOSYLATENone (Tentative Approval)
LUMATEPERONE TOSYLATE 10.5MG · CAPSULE
LUMATEPERONE TOSYLATENone (Tentative Approval)
LUMATEPERONE TOSYLATE 21MG · CAPSULE
Approval history
2025-05-01UNKNOWN · Original · standardTA
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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