← FDA Drug Approvals (Drugs@FDA)
LUMATEPERONE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2025-05-27
Drug application
- FDA Application #
ANDA219200- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LUMATEPERONE
- Generic name
- Lumateperone
- Active ingredients
- LUMATEPERONE
- Dosage form
- CAPSULE
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- ALKEM LABS LTD
- First approval
- 2025-05-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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