Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219200
Company: ALKEM LABS LTD

Products on ANDA 219200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LUMATEPERONE	LUMATEPERONE	10.5MG	CAPSULE	None (Tentative Approval)	None	No	No
LUMATEPERONE	LUMATEPERONE	21MG	CAPSULE	None (Tentative Approval)	None	No	No
LUMATEPERONE	LUMATEPERONE	42MG	CAPSULE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.