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Last Updated: January 26, 2021

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Details for New Drug Application (NDA): 200655

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NDA 200655 describes FLUORODOPA F18, which is a drug marketed by Feinstein and is included in one NDA. It is available from one supplier. Additional details are available on the FLUORODOPA F18 profile page.

The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. One supplier is listed for this compound. Additional details are available on the fluorodopa f-18 profile page.
Summary for 200655
Tradename:FLUORODOPA F18
Applicant:Feinstein
Ingredient:fluorodopa f-18
Patents:0
Generic Entry Opportunity Date for 200655
Generic Entry Date for 200655*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 200655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUORODOPA F18 fluorodopa f-18 SOLUTION;INTRAVENOUS 200655 NDA THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH 13267-345 13267-345-56 25 mL in 1 VIAL, GLASS (13267-345-56)
FLUORODOPA F18 fluorodopa f-18 SOLUTION;INTRAVENOUS 200655 NDA THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH 13267-346 13267-346-57 30 mL in 1 VIAL, GLASS (13267-346-57)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength0.42-8.33mCi/ML
Approval Date:Oct 10, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 10, 2024
Regulatory Exclusivity Use:

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