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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207995
Company: FIRST TIME US GENERICS LLC

Products on ANDA 207995

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LURASIDONE HYDROCHLORIDE	LURASIDONE HYDROCHLORIDE	UNKNOWN	UNKNOWN	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207995

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2018	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.

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