Assyro AI

Orange Book product · Generic (ANDA)

TERIPARATIDE

TERIPARATIDE

Generic (ANDA)ANDA 208569TE APRX TEVA PHARMS USA

At a glance

Nov 16, 2023

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 16, 2023

    2 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TERIPARATIDE

Strength

0.56MG/2.24ML (0.25MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

AP

Application

ANDA 208569

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TERIPARATIDE

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.