Details for New Drug Application (NDA): 017243
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NDA 017243 describes ULTRA-TECHNEKOW FM, which is a drug marketed by Curium and is included in one NDA. It is available from one supplier. Additional details are available on the ULTRA-TECHNEKOW FM profile page.
The generic ingredient in ULTRA-TECHNEKOW FM is technetium tc-99m sodium pertechnetate generator. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate generator profile page.
The generic ingredient in ULTRA-TECHNEKOW FM is technetium tc-99m sodium pertechnetate generator. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate generator profile page.
Summary for 017243
| Tradename: | ULTRA-TECHNEKOW FM |
| Applicant: | Curium |
| Ingredient: | technetium tc-99m sodium pertechnetate generator |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017243
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ULTRA-TECHNEKOW FM | technetium tc-99m sodium pertechnetate generator | SOLUTION;INTRAVENOUS | 017243 | NDA | Curium US LLC | 69945-010 | 69945-010-03 | 1 INJECTION, SOLUTION in 1 CARTON (69945-010-03) |
| ULTRA-TECHNEKOW FM | technetium tc-99m sodium pertechnetate generator | SOLUTION;INTRAVENOUS | 017243 | NDA | Curium US LLC | 69945-015 | 69945-015-04 | 1 INJECTION, SOLUTION in 1 CARTON (69945-015-04) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.25-3 CI/GENERATOR | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1-19 CI/GENERATOR | ||||
| Approval Date: | Feb 18, 2014 | TE: | RLD: | Yes | |||||
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