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Natpara

parathyroid hormone

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Natpara

Proper name

parathyroid hormone

Licence type

351(a)

BLA number

125511

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CDER

Presentations

4

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MCG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	January 23, 2015
25MCG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	January 23, 2015
50MCG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	January 23, 2015
75MCG	For Injection	Subcutaneous	Multi-Dose Vial	Rx	January 23, 2015

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 23, 2022

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity