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Orange Book product · Brand (NDA)

BONSITY

TERIPARATIDE

Brand (NDA)NDA 211939RX ALVOGEN
View TERIPARATIDE familyOpen on FDA Orange Book

At a glance

Oct 04, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 04, 2019

    6 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TERIPARATIDE

Strength

0.56MG/2.24ML (0.25MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 211939

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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

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