Assyro AI

Orange Book product · Generic (ANDA)

TASIMELTEON

TASIMELTEON

Generic (ANDA)ANDA 211601TE ABRX TEVA PHARMS USA INC

At a glance

Dec 12, 2022

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 12, 2022

    3 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TASIMELTEON

Strength

20MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 211601

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TASIMELTEON

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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