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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210828

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NDA 210828 describes GALLIUM DOTATOC GA 68, which is a drug marketed by Uihc Pet Imaging and is included in one NDA. It is available from one supplier. Additional details are available on the GALLIUM DOTATOC GA 68 profile page.

The generic ingredient in GALLIUM DOTATOC GA 68 is gallium dotatoc ga-68 . There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium dotatoc ga-68 profile page.
Summary for 210828
Tradename:GALLIUM DOTATOC GA 68
Applicant:Uihc Pet Imaging
Ingredient:gallium dotatoc ga-68
Patents:0
Generic Entry Opportunity Date for 210828
Generic Entry Date for 210828*:
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.

Suppliers and Packaging for NDA: 210828
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GALLIUM DOTATOC GA 68 gallium dotatoc ga-68 SOLUTION;INTRAVENOUS 210828 NDA UIHC ? P E T Imaging Center 24417-681 24417-681-30 14 mL in 1 VIAL, MULTI-DOSE (24417-681-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength0.5-4mCi/ML
Approval Date:Aug 21, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 21, 2024
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:Aug 21, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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