← FDA Drug Approvals (Drugs@FDA)

PITOLISANT

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA PRIVATE LIMITED · Approved 2025-09-02

Drug application

FDA Application #

ANDA218832

Application type

Abbreviated New Drug Application (Generic)

Brand name

PITOLISANT

Generic name

Pitolisant

Active ingredients

PITOLISANT

Dosage form

TABLET

Route

—

Marketing status

None (Tentative Approval)

Sponsor

ANNORA PHARMA PRIVATE LIMITED

First approval

2025-09-02

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown