Details for New Drug Application (NDA): 212642
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NDA 212642 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.
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 212642
| Tradename: | GALLIUM GA 68 GOZETOTIDE |
| Applicant: | Univ Ca Los Angeles |
| Ingredient: | gallium ga-68 gozetotide |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for NDA: 212642
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 212642
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALLIUM GA 68 GOZETOTIDE | gallium ga-68 gozetotide | SOLUTION;INTRAVENOUS | 212642 | NDA | UCLA Biomedical Cyclotron | 76394-2642 | 76394-2642-3 | 12 mL in 1 VIAL, MULTI-DOSE (76394-2642-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5-5mCi/mL | ||||
| Approval Date: | Dec 1, 2020 | TE: | 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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