Details for New Drug Application (NDA): 017771
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NDA 017771 describes TECHNELITE, which is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNELITE profile page.
The generic ingredient in TECHNELITE 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 TECHNELITE 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 017771
| Tradename: | TECHNELITE |
| Applicant: | Lantheus Medcl |
| Ingredient: | technetium tc-99m sodium pertechnetate generator |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017771
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNELITE | technetium tc-99m sodium pertechnetate generator | SOLUTION;INTRAVENOUS | 017771 | NDA | Lantheus Medical Imaging, Inc. | 11994-090 | 11994-090-01 | 1 VIAL in 1 CARTON (11994-090-01) / 12 mL in 1 VIAL |
| TECHNELITE | technetium tc-99m sodium pertechnetate generator | SOLUTION;INTRAVENOUS | 017771 | NDA | Lantheus Medical Imaging, Inc. | 11994-090 | 11994-090-03 | 1 VIAL in 1 CARTON (11994-090-03) / 16 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.0083-2.7 CI/GENERATOR | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1-20 CI/GENERATOR | ||||
| Approval Date: | Feb 12, 2014 | TE: | RLD: | Yes | |||||
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