Details for New Drug Application (NDA): 208870
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NDA 208870 describes DRAX EXAMETAZIME, which is a drug marketed by Jubilant and is included in one NDA. It is available from one supplier. Additional details are available on the DRAX EXAMETAZIME profile page.
The generic ingredient in DRAX EXAMETAZIME is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.
The generic ingredient in DRAX EXAMETAZIME is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.
Summary for 208870
| Tradename: | DRAX EXAMETAZIME |
| Applicant: | Jubilant |
| Ingredient: | technetium tc-99m exametazime kit |
| Patents: | 0 |
Pharmacology for NDA: 208870
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 208870
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRAX EXAMETAZIME | technetium tc-99m exametazime kit | POWDER;INTRAVENOUS | 208870 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-200 | 65174-200-05 | 5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | N/A | ||||
| Approval Date: | Aug 17, 2017 | TE: | RLD: | No | |||||
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