Assyro AI

Orange Book product · Generic (ANDA)

ULSPIRA

NITRIC OXIDE

Generic (ANDA)ANDA 203144TE AARX AIRGAS THERAP

At a glance

Jul 27, 2023

Approved

Generic (ANDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 27, 2023

    2 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NITRIC OXIDE

Strength

800PPM

Dosage form

GAS

Route

INHALATION

TE code

AA

Application

ANDA 203144

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NITRIC OXIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.