Details for New Drug Application (NDA): 212155

NDA 212155 describes CERIANNA, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from one supplier. Additional details are available on the CERIANNA profile page.

The generic ingredient in CERIANNA is fluoroestradiol f-18. One supplier is listed for this compound. Additional details are available on the fluoroestradiol f-18 profile page.

Summary for 212155

Tradename:	CERIANNA
Applicant:	Ge Healthcare
Ingredient:	fluoroestradiol f-18
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 212155

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.

Pharmacology for NDA: 212155

Mechanism of Action

Positron Emitting Activity

Suppliers and Packaging for NDA: 212155

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CERIANNA	fluoroestradiol f-18	SOLUTION;INTRAVENOUS	212155	NDA	GE Healthcare Inc.	72874-001	72874-001-01	50 mL in 1 VIAL, MULTI-DOSE (72874-001-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	50ML (4-100mCi/ML)
Approval Date:	May 20, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 20, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY

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