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FDA NDA · NDA208743

TYMLOS

abaloparatide

Sponsor: RADIUS

APPLICATION
NDA208743
TYPE
NDA
ORIGINAL APPROVAL
2017-04-28
LATEST ACTION
2025-03-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TYMLOS · ReferencePrescription
ABALOPARATIDE 3.12MG/1.56ML (2MG/ML) · SOLUTION · SUBCUTANEOUS

Approval history

2025-03-28Labeling · Supplement 17 · standard — Medication Guide ↗AP
2023-12-21Labeling · Supplement 15 · standard — Letter ↗AP
2022-12-19Efficacy · Supplement 13 · standard — Label ↗AP
2021-12-22Efficacy · Supplement 10 · standard — Label ↗AP
2021-09-20Efficacy · Supplement 9 · standard — Label ↗AP
2020-10-23Labeling · Supplement 7 · standard — Letter ↗AP
2018-10-17Efficacy · Supplement 3 · standard — Label ↗AP
2018-06-20Labeling · Supplement 4 · standard — Letter ↗AP
2018-02-05Labeling · Supplement 1 · standard — Label ↗AP
2017-04-28Type 1 - New Molecular Entity · 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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