Assyro AI

Orange Book product · Brand (NDA)

ALVAIZ

ELTROMBOPAG CHOLINE

Brand (NDA)NDA 216774RX TEVA PHARMS INC

At a glance

Nov 29, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

3

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 29, 2023

    2 yr 7 mo ago

  2. Today

  3. Patent 11072586 expires

    Listed drug substance patent expiration.

    Nov 05, 2038

    in 12 yr 7 mo

  4. Patent 11072586 expires

    Listed drug substance patent expiration.

    Nov 05, 2038

    in 12 yr 7 mo

  5. Patent 11072586 expires

    Listed drug substance patent expiration.

    Nov 05, 2038

    in 12 yr 7 mo

Pharmaceutical detail

Active ingredient

ELTROMBOPAG CHOLINE

Strength

EQ 9MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 216774

Product number

001

Marketing status

RX

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 (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11072586Nov 05, 2038in 12 yr 7 mo
SubstanceProductU-3936
11072586Nov 05, 2038in 12 yr 7 mo
SubstanceProductU-3937
11072586Nov 05, 2038in 12 yr 7 mo
SubstanceProductU-3938
Agent CTA Background

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