← FDA DRUG APPROVALS

FDA NDA · NDA212123

TAUVID

flortaucipir f-18

Sponsor: AVID RADIOPHARMS INC

APPLICATION
NDA212123
TYPE
NDA
ORIGINAL APPROVAL
2020-05-28
LATEST ACTION
2024-02-05
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

TAUVID · ReferencePrescription
FLORTAUCIPIR F-18 100ML (8.1-100mCi/ML) · SOLUTION · INTRAVENOUS
TAUVID · ReferenceDiscontinued
FLORTAUCIPIR F-18 50ML (8.1-51mCi/ML) · SOLUTION · INTRAVENOUS
TAUVID · ReferencePrescription
FLORTAUCIPIR F-18 50ML (8.1-100mCi/ML) · SOLUTION · INTRAVENOUS
TAUVID · ReferenceDiscontinued
FLORTAUCIPIR F-18 30ML (8.1-51mCi/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-02-05Labeling · Supplement 31 · standard — Label ↗AP
2022-07-01Manufacturing (CMC) · Supplement 4 — Label ↗AP
2020-05-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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