Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218495
Company: NOVITIUM PHARMA LLC

Products on ANDA 218495

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PITOLISANT	PITOLISANT	4.45MG	TABLET	None (Tentative Approval)	None	No	No
PITOLISANT	PITOLISANT	17.8MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218495

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.