Details for New Drug Application (NDA): 215168
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The generic ingredient in FLYRCADO is flurpiridaz f-18. One supplier is listed for this compound. Additional details are available on the flurpiridaz f-18 profile page.
Summary for 215168
Tradename: | FLYRCADO |
Applicant: | Ge Hlthcare |
Ingredient: | flurpiridaz f-18 |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215168
Generic Entry Date for 215168*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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: 215168
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLYRCADO | flurpiridaz f-18 | SOLUTION;INTRAVENOUS | 215168 | NDA | GE Healthcare | 0407-8787 | 0407-8787-01 | 30 mL in 1 VIAL, GLASS (0407-8787-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5-55mCi/ML | ||||
Approval Date: | Sep 27, 2024 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Sep 27, 2029 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | May 26, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | ⤷ Subscribe | Patent Expiration: | Jun 21, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING |
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