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Last Updated: June 28, 2022

Details for New Drug Application (NDA): 212642


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NDA 212642 describes GALLIUM GA 68 PSMA-11, 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 one supplier. Additional details are available on the GALLIUM GA 68 PSMA-11 profile page.

The generic ingredient in GALLIUM GA 68 PSMA-11 is gallium ga-68 psma-11. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium ga-68 psma-11 profile page.
Summary for 212642
Tradename:GALLIUM GA 68 PSMA-11
Applicant:Univ Ca Los Angeles
Ingredient:gallium ga-68 psma-11
Patents:0
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 212642
Generic Entry Date for 212642*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength30ML (0.5-5mCi/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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