Orange Book product · Brand (NDA)

INOMAX

NITRIC OXIDE

Brand (NDA)NDA 020845RX MALLINCKRODT IRELAND

Jan 17, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 17, 2023
3 yr 6 mo ago
Today
Patent 11931377 expires
Listed drug substance patent expiration.
Jun 30, 2029
in 3 yr 1 mo

Active ingredient

NITRIC OXIDE

Strength

4880PPM

Dosage form

GAS

Route

INHALATION

TE code

Not listed

Application

NDA 020845

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11931377	Jun 30, 2029	in 3 yr 1 mo	SubstanceProductU-3903