Assyro AI

Orange Book product · Brand (NDA)

KATERZIA

AMLODIPINE BENZOATE

Brand (NDA)NDA 211340RX AZURITY
View AMLODIPINE BENZOATE familyOpen on FDA Orange Book

At a glance

Jul 08, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

18

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 08, 2019

    7 yr 1 mo ago

  2. Today

  3. Patent 10894039 expires

    Listed method-of-use patent (U-3) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  4. Patent 10894039 expires

    Listed method-of-use patent (U-185) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  5. Patent 10952998 expires

    Listed drug product patent expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  6. Patent 10959991 expires

    Listed method-of-use patent (U-39) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  7. Patent 10959991 expires

    Listed method-of-use patent (U-158) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  8. Patent 11364230 expires

    Listed drug product patent expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  9. Patent 11471409 expires

    Listed method-of-use patent (U-3447) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  10. Patent 11471409 expires

    Listed method-of-use patent (U-3448) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  11. Patent 11484498 expires

    Listed drug product patent expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  12. Patent 11701326 expires

    Listed drug product patent expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  13. Patent 11918685 expires

    Listed method-of-use patent (U-3447) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  14. Patent 11918685 expires

    Listed method-of-use patent (U-3448) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  15. Patent 12053461 expires

    Listed drug product patent expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  16. Patent 12336984 expires

    Listed method-of-use patent (U-3447) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  17. Patent 12336984 expires

    Listed method-of-use patent (U-3448) expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  18. Patent 12383498 expires

    Listed drug product patent expiration.

    Oct 06, 2037

    in 11 yr 6 mo

  19. Patent 10695329 expires

    Listed drug product patent expiration.

    Oct 16, 2037

    in 11 yr 6 mo

  20. Patent 10799453 expires

    Listed drug product patent expiration.

    Apr 11, 2039

    in 13 yr

Pharmaceutical detail

Active ingredient

AMLODIPINE BENZOATE

Strength

EQ 1MG BASE/ML

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 211340

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 (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10894039Oct 06, 2037in 11 yr 6 mo
U-3
10894039Oct 06, 2037in 11 yr 6 mo
U-185
10952998Oct 06, 2037in 11 yr 6 mo
Product
10959991Oct 06, 2037in 11 yr 6 mo
U-39
10959991Oct 06, 2037in 11 yr 6 mo
U-158
11364230Oct 06, 2037in 11 yr 6 mo
Product
11471409Oct 06, 2037in 11 yr 6 mo
U-3447
11471409Oct 06, 2037in 11 yr 6 mo
U-3448
11484498Oct 06, 2037in 11 yr 6 mo
Product
11701326Oct 06, 2037in 11 yr 6 mo
Product
11918685Oct 06, 2037in 11 yr 6 mo
U-3447
11918685Oct 06, 2037in 11 yr 6 mo
U-3448
12053461Oct 06, 2037in 11 yr 6 mo
Product
12336984Oct 06, 2037in 11 yr 6 mo
U-3447
12336984Oct 06, 2037in 11 yr 6 mo
U-3448
12383498Oct 06, 2037in 11 yr 6 mo
Product
10695329Oct 16, 2037in 11 yr 6 mo
Product
10799453Apr 11, 2039in 13 yr
Product
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