Details for New Drug Application (NDA): 212642
✉ Email this page to a colleague
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. Six 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. Six 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 |
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 | |||||
Complete Access Available with Subscription
