Details for New Drug Application (NDA): 017321
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NDA 017321 describes SODIUM PERTECHNETATE TC 99M, which is a drug marketed by Ge Healthcare, Mallinckrodt, and Pharmalucence, and is included in three NDAs. Additional details are available on the SODIUM PERTECHNETATE TC 99M profile page.
The generic ingredient in SODIUM PERTECHNETATE TC 99M is technetium tc-99m sodium pertechnetate. There are four drug master file entries for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate profile page.
The generic ingredient in SODIUM PERTECHNETATE TC 99M is technetium tc-99m sodium pertechnetate. There are four drug master file entries for this compound. Additional details are available on the technetium tc-99m sodium pertechnetate profile page.
Summary for 017321
| Tradename: | SODIUM PERTECHNETATE TC 99M |
| Applicant: | Pharmalucence |
| Ingredient: | technetium tc-99m sodium pertechnetate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INJECTION, ORAL | Strength | 12mCi/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INJECTION, ORAL | Strength | 24mCi/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INJECTION, ORAL | Strength | 48mCi/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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