Teriparatide Apotex (teriparatide)

ANDA 211097

Teriparatide Apotex (teriparatide)

ANDA 211097

U.S. License Holder:

Apotex / Ambio

Date of License:

November-16-2023

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

TERIPARATIDE APOTEX (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for:

Treatment of postmenopausal women with osteoporosis at high risk for fracture;

Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture;

Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Methodology

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