← FDA Drug Approvals (Drugs@FDA)

PITOLISANT

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: LUPIN LIMITED · Approved 2026-03-23

Drug application

FDA Application #

ANDA218846

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

LUPIN LIMITED

First approval

2026-03-23

Source

Authoritative

Drugs@FDA application overview

Machine

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