Details for New Drug Application (NDA): 215146
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NDA 215146 describes TECHNETIUM TC-99M PENTETATE KIT, which is a drug marketed by Curium and Ge Healthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the TECHNETIUM TC-99M PENTETATE KIT profile page.
The generic ingredient in TECHNETIUM TC-99M PENTETATE KIT is technetium tc-99m pentetate kit. 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 pentetate kit profile page.
The generic ingredient in TECHNETIUM TC-99M PENTETATE KIT is technetium tc-99m pentetate kit. 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 pentetate kit profile page.
Summary for 215146
| Tradename: | TECHNETIUM TC-99M PENTETATE KIT |
| Applicant: | Curium |
| Ingredient: | technetium tc-99m pentetate kit |
| Patents: | 0 |
Pharmacology for NDA: 215146
| Mechanism of Action | Lead Chelating Activity |
Suppliers and Packaging for NDA: 215146
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNETIUM TC-99M PENTETATE KIT | technetium tc-99m pentetate kit | INJECTABLE;INJECTION | 215146 | ANDA | Curium US LLC | 69945-314 | 69945-314-05 | 5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01) |
| TECHNETIUM TC-99M PENTETATE KIT | technetium tc-99m pentetate kit | INJECTABLE;INJECTION | 215146 | ANDA | Curium US LLC | 69945-314 | 69945-314-30 | 30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Mar 26, 2025 | TE: | AP | RLD: | No | ||||
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