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Last Updated: June 28, 2022

Details for New Drug Application (NDA): 212643


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NDA 212643 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 212643
Tradename:GALLIUM GA 68 PSMA-11
Applicant:Univ Of Ca San Fran
Ingredient:gallium ga-68 psma-11
Patents:0
DrugPatentWatch® Estimated Generic Entry Opportunity 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 PSMA-11 gallium ga-68 psma-11 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;INTRAVENOUSStrength20ML (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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.