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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212123
Company: AVID RADIOPHARMS INC

Products on NDA 212123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAUVID	FLORTAUCIPIR F-18	30ML (8.1-51mCi/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
TAUVID	FLORTAUCIPIR F-18	50ML (8.1-51mCi/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No
TAUVID	FLORTAUCIPIR F-18	50ML (8.1-100mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes
TAUVID	FLORTAUCIPIR F-18	100ML (8.1-100mCi/ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212123s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212123Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212123Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-31	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212123s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212123Orig1s031ltr.pdf
07/01/2022	SUPPL-4	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212123Orig1s004lbl.pdf

Labels for NDA 212123

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/05/2024	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212123s031lbl.pdf
07/01/2022	SUPPL-4	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212123Orig1s004lbl.pdf
05/28/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212123s000lbl.pdf

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