Details for New Drug Application (NDA): 050779
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NDA 050779 describes CEFAZOLIN AND DEXTROSE, 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 CEFAZOLIN AND DEXTROSE profile page.
The generic ingredient in CEFAZOLIN AND DEXTROSE is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
The generic ingredient in CEFAZOLIN AND DEXTROSE is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 050779
| Tradename: | CEFAZOLIN AND DEXTROSE |
| Applicant: | B Braun |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050779
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN AND DEXTROSE | cefazolin sodium | INJECTABLE;INJECTION | 050779 | NDA | B. Braun Medical Inc. | 0264-3103 | 0264-3103-11 | 24 CONTAINER in 1 CASE (0264-3103-11) / 50 mL in 1 CONTAINER |
| CEFAZOLIN AND DEXTROSE | cefazolin sodium | INJECTABLE;INJECTION | 050779 | NDA | B. Braun Medical Inc. | 0264-3105 | 0264-3105-11 | 24 CONTAINER in 1 CASE (0264-3105-11) / 50 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jul 27, 2000 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | Jul 27, 2000 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | Jan 13, 2012 | TE: | RLD: | Yes | |||||
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