Assyro AI

Orange Book product · Brand (NDA)

INOMAX

NITRIC OXIDE

Brand (NDA)NDA 020845DISCN MALLINCKRODT IRELAND

At a glance

Dec 23, 1999

Approved

Brand (NDA)

Application

Not listed

TE code

20

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 23, 1999

    26 yr 11 mo ago

  2. Today

  3. Patent 8282966 expires

    Listed method-of-use patent (U-1286) expiration.

    Jun 30, 2029

    in 3 yr 1 mo

  4. Patent 8293284 expires

    Listed method-of-use patent (U-1286) expiration.

    Jun 30, 2029

    in 3 yr 1 mo

  5. Patent 8431163 expires

    Listed method-of-use patent (U-1286) expiration.

    Jun 30, 2029

    in 3 yr 1 mo

  6. Patent 8795741 expires

    Listed method-of-use patent (U-1286) expiration.

    Jun 30, 2029

    in 3 yr 1 mo

  7. Patent 8846112 expires

    Listed method-of-use patent (U-1286) expiration.

    Jun 30, 2029

    in 3 yr 1 mo

  8. Patent 8282966*PED expires

    Listed listed patent expiration.

    Dec 30, 2029

    in 3 yr 7 mo

  9. Patent 8293284*PED expires

    Listed listed patent expiration.

    Dec 30, 2029

    in 3 yr 7 mo

  10. Patent 8431163*PED expires

    Listed listed patent expiration.

    Dec 30, 2029

    in 3 yr 7 mo

  11. Patent 8795741*PED expires

    Listed listed patent expiration.

    Dec 30, 2029

    in 3 yr 7 mo

  12. Patent 8846112*PED expires

    Listed listed patent expiration.

    Dec 30, 2029

    in 3 yr 7 mo

  13. Patent 8291904 expires

    Listed drug product patent expiration.

    Jan 06, 2031

    in 4 yr 7 mo

  14. Patent 8573209 expires

    Listed drug product patent expiration.

    Jan 06, 2031

    in 4 yr 7 mo

  15. Patent 8573210 expires

    Listed drug product patent expiration.

    Jan 06, 2031

    in 4 yr 7 mo

  16. Patent 8776794 expires

    Listed drug product patent expiration.

    Jan 06, 2031

    in 4 yr 7 mo

  17. Patent 8776795 expires

    Listed drug product patent expiration.

    Jan 06, 2031

    in 4 yr 7 mo

  18. Patent 8291904*PED expires

    Listed listed patent expiration.

    Jul 06, 2031

    in 5 yr 1 mo

  19. Patent 8573209*PED expires

    Listed listed patent expiration.

    Jul 06, 2031

    in 5 yr 1 mo

  20. Patent 8573210*PED expires

    Listed listed patent expiration.

    Jul 06, 2031

    in 5 yr 1 mo

  21. Patent 8776794*PED expires

    Listed listed patent expiration.

    Jul 06, 2031

    in 5 yr 1 mo

  22. Patent 8776795*PED expires

    Listed listed patent expiration.

    Jul 06, 2031

    in 5 yr 1 mo

Pharmaceutical detail

Active ingredient

NITRIC OXIDE

Strength

100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

GAS

Route

INHALATION

TE code

Not listed

Application

NDA 020845

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

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

Listed patents (20)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8282966Jun 30, 2029in 3 yr 1 mo
U-1286
8293284Jun 30, 2029in 3 yr 1 mo
U-1286
8431163Jun 30, 2029in 3 yr 1 mo
U-1286
8795741Jun 30, 2029in 3 yr 1 mo
U-1286
8846112Jun 30, 2029in 3 yr 1 mo
U-1286
8282966*PEDDec 30, 2029in 3 yr 7 mo
8293284*PEDDec 30, 2029in 3 yr 7 mo
8431163*PEDDec 30, 2029in 3 yr 7 mo
8795741*PEDDec 30, 2029in 3 yr 7 mo
8846112*PEDDec 30, 2029in 3 yr 7 mo
8291904Jan 06, 2031in 4 yr 7 mo
ProductU-1226
8573209Jan 06, 2031in 4 yr 7 mo
Product
8573210Jan 06, 2031in 4 yr 7 mo
ProductU-1453
8776794Jan 06, 2031in 4 yr 7 mo
ProductU-1226
8776795Jan 06, 2031in 4 yr 7 mo
ProductU-1226
8291904*PEDJul 06, 2031in 5 yr 1 mo
8573209*PEDJul 06, 2031in 5 yr 1 mo
8573210*PEDJul 06, 2031in 5 yr 1 mo
8776794*PEDJul 06, 2031in 5 yr 1 mo
8776795*PEDJul 06, 2031in 5 yr 1 mo
Agent CTA Background

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