Details for New Drug Application (NDA): 219189
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NDA 219189 describes GALLIUM GA-68 GOZETOTIDE, which is a drug marketed by Ionetix and is included in one NDA. It is available from one supplier. 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 219189
| Tradename: | GALLIUM GA-68 GOZETOTIDE |
| Applicant: | Ionetix |
| Ingredient: | gallium ga-68 gozetotide |
| Patents: | 0 |
Pharmacology for NDA: 219189
| Mechanism of Action | Positron Emitting Activity |
Suppliers and Packaging for NDA: 219189
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALLIUM GA-68 GOZETOTIDE | gallium ga-68 gozetotide | SOLUTION;INTRAVENOUS | 219189 | ANDA | Ionetix Corporation | 71162-201 | 71162-201-10 | 9 mL in 1 SYRINGE (71162-201-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5-5mCi/mL | ||||
| Approval Date: | May 14, 2026 | TE: | AP | RLD: | No | ||||
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