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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212643


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NDA 212643 describes GALLIUM GA 68 GOZETOTIDE, which is a drug marketed by Univ Ca Los Angeles and Univ Of Ca San Fran and is included in two NDAs. It is available from two suppliers. Additional details are available on the GALLIUM GA 68 GOZETOTIDE profile page.

The generic ingredient in GALLIUM GA 68 GOZETOTIDE is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.
Summary for 212643
Tradename:GALLIUM GA 68 GOZETOTIDE
Applicant:Univ Of Ca San Fran
Ingredient:gallium ga-68 gozetotide
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212643
Generic Entry Date for 212643*:
Constraining patent/regulatory exclusivity:
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED 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.

Pharmacology for NDA: 212643
Mechanism of ActionPositron Emitting Activity
Suppliers and Packaging for NDA: 212643
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALLIUM GA 68 GOZETOTIDE gallium ga-68 gozetotide SOLUTION;INTRAVENOUS 212643 NDA UCSF Radiopharmaceutical Facility 24275-0525 24275-0525-1 11 mL in 1 VIAL, MULTI-DOSE (24275-0525-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.5-5mCi/mL
Approval Date:Dec 1, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 1, 2025
Regulatory Exclusivity Use:EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Regulatory Exclusivity Expiration:Dec 1, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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