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FDA NDA · NDA208325

PARSABIV

etelcalcetide

Sponsor: KAI PHARMS INC

APPLICATION
NDA208325
TYPE
NDA
ORIGINAL APPROVAL
2017-02-07
LATEST ACTION
2021-02-11
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PARSABIV · ReferencePrescription
ETELCALCETIDE 5MG/ML (5MG/ML) · SOLUTION · INTRAVENOUS
PARSABIV · ReferencePrescription
ETELCALCETIDE 10MG/2ML (5MG/ML) · SOLUTION · INTRAVENOUS
PARSABIV · ReferencePrescription
ETELCALCETIDE 2.5MG/0.5ML (2.5MG/0.5ML) · SOLUTION · INTRAVENOUS

Approval history

2021-02-11Labeling · Supplement 5 · standard — Letter ↗AP
2019-03-08Labeling · Supplement 2 · standard — Letter ↗AP
2018-08-20Labeling · Supplement 1 · standard — Label ↗AP
2017-02-07Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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