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FDA NDA · NDA218771

TERIPARATIDE

Sponsor: ALMAJECT

APPLICATION
NDA218771
TYPE
NDA
ORIGINAL APPROVAL
2024-06-04
LATEST ACTION
2025-01-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2025-01-23Labeling · Supplement 1 · standardLabelAP
2024-06-04Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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