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Drugs@FDA: FDA-Approved Drugs

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