Details for New Drug Application (NDA): 216820
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NDA 216820 describes TECHNETIUM TC 99M MERTIATIDE KIT, which is a drug marketed by Jubilant Draximage and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNETIUM TC 99M MERTIATIDE KIT profile page.
The generic ingredient in TECHNETIUM TC 99M MERTIATIDE KIT is technetium tc-99m mertiatide 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 mertiatide kit profile page.
The generic ingredient in TECHNETIUM TC 99M MERTIATIDE KIT is technetium tc-99m mertiatide 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 mertiatide kit profile page.
Summary for 216820
| Tradename: | TECHNETIUM TC 99M MERTIATIDE KIT |
| Applicant: | Jubilant Draximage |
| Ingredient: | technetium tc-99m mertiatide kit |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216820
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNETIUM TC 99M MERTIATIDE KIT | technetium tc-99m mertiatide kit | POWDER;INTRAVENOUS | 216820 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-261 | 65174-261-05 | 5 VIAL in 1 CARTON (65174-261-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-261-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | N/A | ||||
| Approval Date: | Jan 30, 2023 | TE: | RLD: | Yes | |||||
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