Details for New Drug Application (NDA): 018035
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NDA 018035 describes DRAXIMAGE MDP-25, 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 MDP-25 profile page.
The generic ingredient in DRAXIMAGE MDP-25 is technetium tc-99m medronate. 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 medronate profile page.
The generic ingredient in DRAXIMAGE MDP-25 is technetium tc-99m medronate. 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 medronate profile page.
Summary for 018035
| Tradename: | DRAXIMAGE MDP-25 |
| Applicant: | Jubilant |
| Ingredient: | technetium tc-99m medronate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018035
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRAXIMAGE MDP-10 | technetium tc-99m medronate | INJECTABLE;INJECTION | 018035 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-660 | 65174-660-30 | 30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30) |
| DRAXIMAGE MDP-25 | technetium tc-99m medronate | INJECTABLE;INJECTION | 018035 | NDA | Jubilant DraxImage Inc., dba Jubilant Radiopharma | 65174-660 | 65174-660-30 | 30 INJECTION, POWDER, FOR SOLUTION in 1 CARTON (65174-660-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Feb 27, 2004 | TE: | RLD: | Yes | |||||
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