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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202008

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AMYVID (FLORBETAPIR F-18)
10-30ML (13.5-51mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLORBETAPIR F-18
Proprietary Name: AMYVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10-30ML (13.5-51mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202008
Product Number: 002
Approval Date: Apr 6, 2012
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
AMYVID (FLORBETAPIR F-18)
10-50ML (13.5-51mCi/ML)
Marketing Status: Prescription
Active Ingredient: FLORBETAPIR F-18
Proprietary Name: AMYVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10-50ML (13.5-51mCi/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202008
Product Number: 003
Approval Date: Apr 6, 2012
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
AMYVID (FLORBETAPIR F-18)
10ML (13.5-51mCi/ML)
Marketing Status: Discontinued
Active Ingredient: FLORBETAPIR F-18
Proprietary Name: AMYVID
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10ML (13.5-51mCi/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N202008
Product Number: 001
Approval Date: Apr 6, 2012
Applicant Holder Full Name: AVID RADIOPHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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