Details for New Drug Application (NDA): 018511
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NDA 018511 describes DRAXIMAGE DTPA, which is a drug marketed by Jubilant and is included in one NDA. It is available from one supplier. Additional details are available on the DRAXIMAGE DTPA profile page.
The generic ingredient in DRAXIMAGE DTPA 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 DRAXIMAGE DTPA 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 018511
| Tradename: | DRAXIMAGE DTPA |
| Applicant: | Jubilant |
| Ingredient: | technetium tc-99m pentetate kit |
| Patents: | 0 |
Pharmacology for NDA: 018511
| Mechanism of Action | Lead Chelating Activity |
Suppliers and Packaging for NDA: 018511
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRAXIMAGE DTPA | technetium tc-99m pentetate kit | INJECTABLE;INJECTION | 018511 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-288 | 65174-288-30 | 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT (65174-288-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Dec 29, 1989 | TE: | AP | RLD: | Yes | ||||
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