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FDA NDA · NDA211939

TERIPARATIDE

Sponsor: ALVOGEN

APPLICATION
NDA211939
TYPE
NDA
ORIGINAL APPROVAL
2019-10-04
LATEST ACTION
2025-01-24
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BONSITYPrescription
TERIPARATIDE 0.56MG/2.24ML (0.25MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-01-24Labeling · Supplement 17 · standard — Label ↗AP
2023-11-16Efficacy · Supplement 4 · standard — Label ↗AP
2019-10-04Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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