Details for New Drug Application (NDA): 017478
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NDA 017478 describes GALLIUM CITRATE GA 67, which is a drug marketed by Curium, Ge Healthcare, and Lantheus Medcl, and is included in three NDAs. It is available from two suppliers. Additional details are available on the GALLIUM CITRATE GA 67 profile page.
The generic ingredient in GALLIUM CITRATE GA 67 is gallium citrate ga-67. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gallium citrate ga-67 profile page.
The generic ingredient in GALLIUM CITRATE GA 67 is gallium citrate ga-67. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gallium citrate ga-67 profile page.
Summary for 017478
| Tradename: | GALLIUM CITRATE GA 67 |
| Applicant: | Lantheus Medcl |
| Ingredient: | gallium citrate ga-67 |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 017478
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALLIUM CITRATE GA 67 | gallium citrate ga-67 | INJECTABLE;INJECTION | 017478 | NDA | Lantheus Medical Imaging, Inc. | 11994-121 | 11994-121-06 | 3.3 mL in 1 VIAL (11994-121-06) |
| GALLIUM CITRATE GA 67 | gallium citrate ga-67 | INJECTABLE;INJECTION | 017478 | NDA | Lantheus Medical Imaging, Inc. | 11994-121 | 11994-121-08 | 4.4 mL in 1 VIAL (11994-121-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2mCi/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | BS | RLD: | No | ||||
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