Details for New Drug Application (NDA): 214993
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NDA 214993 describes NEPHROSCAN, which is a drug marketed by Theragnostics and is included in one NDA. It is available from one supplier. Additional details are available on the NEPHROSCAN profile page.
The generic ingredient in NEPHROSCAN is technetium tc-99m succimer. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m succimer profile page.
The generic ingredient in NEPHROSCAN is technetium tc-99m succimer. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m succimer profile page.
Summary for 214993
| Tradename: | NEPHROSCAN |
| Applicant: | Theragnostics |
| Ingredient: | technetium tc-99m succimer |
| Patents: | 0 |
Pharmacology for NDA: 214993
| Mechanism of Action | Lead Chelating Activity |
Suppliers and Packaging for NDA: 214993
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEPHROSCAN | technetium tc-99m succimer | POWDER;INTRAVENOUS | 214993 | NDA | Theragnostics Inc | 71083-0020 | 71083-0020-5 | 5 VIAL, SINGLE-DOSE in 1 CARTON (71083-0020-5) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71083-0020-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | N/A | ||||
| Approval Date: | Feb 18, 2022 | TE: | RLD: | Yes | |||||
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