Details for New Drug Application (NDA): 212643
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NDA 212643 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 212643
| Tradename: | GALLIUM GA 68 GOZETOTIDE |
| Applicant: | Univ Of Ca San Fran |
| Ingredient: | gallium ga-68 gozetotide |
| Patents: | 0 |
Pharmacology for NDA: 212643
| Mechanism of Action | Positron 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 GOZETOTIDE | gallium ga-68 gozetotide | 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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5-5mCi/mL | ||||
| Approval Date: | Dec 1, 2020 | TE: | RLD: | Yes | |||||
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