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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212123

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TAUVID (FLORTAUCIPIR F-18)
30ML (8.1-51mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLORTAUCIPIR F-18
Proprietary Name: TAUVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 30ML (8.1-51mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212123
Product Number: 001
Approval Date: May 28, 2020
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TAUVID (FLORTAUCIPIR F-18)
50ML (8.1-51mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLORTAUCIPIR F-18
Proprietary Name: TAUVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50ML (8.1-51mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212123
Product Number: 002
Approval Date: May 28, 2020
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TAUVID (FLORTAUCIPIR F-18)
50ML (8.1-100mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLORTAUCIPIR F-18
Proprietary Name: TAUVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50ML (8.1-100mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212123
Product Number: 003
Approval Date: Jul 1, 2022
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TAUVID (FLORTAUCIPIR F-18)
100ML (8.1-100mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLORTAUCIPIR F-18
Proprietary Name: TAUVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 100ML (8.1-100mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212123
Product Number: 004
Approval Date: Jul 1, 2022
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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