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Orange Book product · Brand (NDA)

NOURESS

CYSTEINE HYDROCHLORIDE

Brand (NDA)NDA 212535DISCN BAXTER HLTHCARE CORP
View CYSTEINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Dec 13, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

19

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 13, 2019

    6 yr 7 mo ago

  2. Today

  3. Patent 10478453 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  4. Patent 10583155 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  5. Patent 10653719 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  6. Patent 10905713 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  7. Patent 10905714 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  8. Patent 10912795 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  9. Patent 10918662 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  10. Patent 10933089 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  11. Patent 11510942 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  12. Patent 11642370 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  13. Patent 11648262 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  14. Patent 11679125 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  15. Patent 11684636 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  16. Patent 11826383 expires

    Listed drug product patent expiration.

    Jan 15, 2039

    in 12 yr 9 mo

  17. Patent 11510941 expires

    Listed drug product patent expiration.

    Mar 02, 2039

    in 12 yr 11 mo

  18. Patent 10493051 expires

    Listed drug product patent expiration.

    Mar 15, 2039

    in 12 yr 11 mo

  19. Patent 10543186 expires

    Listed method-of-use patent (U-2722) expiration.

    Mar 15, 2039

    in 12 yr 11 mo

  20. Patent 10702490 expires

    Listed drug product patent expiration.

    Mar 15, 2039

    in 12 yr 11 mo

  21. Patent 11045438 expires

    Listed drug product patent expiration.

    Mar 15, 2039

    in 12 yr 11 mo

Pharmaceutical detail

Active ingredient

CYSTEINE HYDROCHLORIDE

Strength

500MG/10ML (50MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 212535

Product number

001

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 (19)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10478453Jan 15, 2039in 12 yr 9 mo
ProductU-2752
10583155Jan 15, 2039in 12 yr 9 mo
ProductU-2752
10653719Jan 15, 2039in 12 yr 9 mo
Product
10905713Jan 15, 2039in 12 yr 9 mo
Product
10905714Jan 15, 2039in 12 yr 9 mo
Product
10912795Jan 15, 2039in 12 yr 9 mo
Product
10918662Jan 15, 2039in 12 yr 9 mo
Product
10933089Jan 15, 2039in 12 yr 9 mo
Product
11510942Jan 15, 2039in 12 yr 9 mo
ProductU-2752
11642370Jan 15, 2039in 12 yr 9 mo
Product
11648262Jan 15, 2039in 12 yr 9 mo
Product
11679125Jan 15, 2039in 12 yr 9 mo
Product
11684636Jan 15, 2039in 12 yr 9 mo
Product
11826383Jan 15, 2039in 12 yr 9 mo
Product
11510941Mar 02, 2039in 12 yr 11 mo
Product
10493051Mar 15, 2039in 12 yr 11 mo
Product
10543186Mar 15, 2039in 12 yr 11 mo
U-2722
10702490Mar 15, 2039in 12 yr 11 mo
Product
11045438Mar 15, 2039in 12 yr 11 mo
Product
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