Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218846
Company: LUPIN

Products on ANDA 218846

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET;ORAL	Prescription	AB	No	No
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218846

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218846

PITOLISANT HYDROCHLORIDE

TABLET;ORAL; EQ 4.45MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET;ORAL	Prescription	No	AB	218846	LUPIN
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET;ORAL	Prescription	No	AB	218873	MSN
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET;ORAL	Prescription	No	AB	218495	NOVITIUM PHARMA
WAKIX	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET;ORAL	Prescription	Yes	AB	211150	HARMONY

TABLET;ORAL; EQ 17.8MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET;ORAL	Prescription	No	AB	218846	LUPIN
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET;ORAL	Prescription	No	AB	218873	MSN
PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET;ORAL	Prescription	No	AB	218495	NOVITIUM PHARMA
WAKIX	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET;ORAL	Prescription	Yes	AB	211150	HARMONY