Assyro AI

Orange Book product · Brand (NDA)

NITHIODOTE

SODIUM NITRITE; SODIUM THIOSULFATE

Brand (NDA)NDA 201444RX HOPE PHARMS

At a glance

Jan 14, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 14, 2011

    15 yr 8 mo ago

  2. Today

  3. Patent 11753301 expires

    Listed drug substance patent expiration.

    Feb 10, 2030

    in 3 yr 8 mo

  4. Patent 12304813 expires

    Listed drug product patent expiration.

    Feb 10, 2030

    in 3 yr 8 mo

  5. Patent 9687506 expires

    Listed drug product patent expiration.

    Feb 10, 2030

    in 3 yr 8 mo

  6. Patent 9687506 expires

    Listed drug product patent expiration.

    Feb 10, 2030

    in 3 yr 8 mo

  7. Patent 10479686 expires

    Listed drug product patent expiration.

    Jul 07, 2030

    in 4 yr 1 mo

  8. Patent 9345724 expires

    Listed drug substance patent expiration.

    Jul 07, 2030

    in 4 yr 1 mo

  9. Patent 9585912 expires

    Listed drug substance patent expiration.

    Jul 07, 2030

    in 4 yr 1 mo

  10. Patent 8496973 expires

    Listed drug substance patent expiration.

    Mar 29, 2031

    in 4 yr 10 mo

  11. Patent 8568793 expires

    Listed drug substance patent expiration.

    Dec 24, 2031

    in 5 yr 7 mo

Pharmaceutical detail

Active ingredient

SODIUM NITRITE; SODIUM THIOSULFATE

Strength

300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)

Dosage form

SOLUTION, SOLUTION

Route

INTRAVENOUS, INTRAVENOUS

TE code

Not listed

Application

NDA 201444

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11753301Feb 10, 2030in 3 yr 8 mo
SubstanceProductU-3681
12304813Feb 10, 2030in 3 yr 8 mo
Product
9687506Feb 10, 2030in 3 yr 8 mo
ProductU-3394
9687506Feb 10, 2030in 3 yr 8 mo
ProductU-3395
10479686Jul 07, 2030in 4 yr 1 mo
ProductU-3390
9345724Jul 07, 2030in 4 yr 1 mo
SubstanceProductU-2015
9585912Jul 07, 2030in 4 yr 1 mo
SubstanceProduct
8496973Mar 29, 2031in 4 yr 10 mo
SubstanceProductU-1419
8568793Dec 24, 2031in 5 yr 7 mo
SubstanceProduct
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