← FDA Drug Approvals (Drugs@FDA)
LUMATEPERONE TOSYLATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABORATORIES PRIVATE LTD · Approved 2025-05-01
Drug application
- FDA Application #
ANDA219248- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LUMATEPERONE TOSYLATE
- Generic name
- Lumateperone Tosylate
- Active ingredients
- LUMATEPERONE TOSYLATE
- Dosage form
- CAPSULE
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- MSN LABORATORIES PRIVATE LTD
- First approval
- 2025-05-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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