Details for New Drug Application (NDA): 050780
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NDA 050780 describes CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER profile page.
The generic ingredient in CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
The generic ingredient in CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER is cefuroxime sodium. There are sixty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.
Summary for 050780
| Tradename: | CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER |
| Applicant: | B Braun |
| Ingredient: | cefuroxime sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050780
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | cefuroxime sodium | INJECTABLE;INJECTION | 050780 | NDA | B. Braun Medical Inc. | 0264-3112 | 0264-3112-11 | 24 CONTAINER in 1 CASE (0264-3112-11) / 50 mL in 1 CONTAINER |
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | cefuroxime sodium | INJECTABLE;INJECTION | 050780 | NDA | B. Braun Medical Inc. | 0264-3114 | 0264-3114-11 | 24 CONTAINER in 1 CASE (0264-3114-11) / 50 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 750MG BASE/VIAL | ||||
| Approval Date: | Feb 21, 2001 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.5GM BASE/VIAL | ||||
| Approval Date: | Feb 21, 2001 | TE: | RLD: | Yes | |||||
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