An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Products on ANDA 218495

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 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
07/21/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218495Orig1s000PanoramaTAltr.pdf

Therapeutic Equivalents for ANDA 218495

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

Top