Details for New Drug Application (NDA): 207131
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NDA 207131 describes CEFAZOLIN IN DEXTROSE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the CEFAZOLIN IN DEXTROSE profile page.
The generic ingredient in CEFAZOLIN IN 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 IN 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 207131
| Tradename: | CEFAZOLIN IN DEXTROSE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | cefazolin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207131
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN IN DEXTROSE | cefazolin sodium | SOLUTION;INTRAVENOUS | 207131 | NDA | Baxter Healthcare Corporation | 0338-0096 | 0338-0096-06 | 6 BAG in 1 CASE (0338-0096-06) / 150 mL in 1 BAG |
| CEFAZOLIN IN DEXTROSE | cefazolin sodium | SOLUTION;INTRAVENOUS | 207131 | NDA | Baxter Healthcare Corporation | 0338-3503 | 0338-3503-41 | 24 BAG in 1 CASE (0338-3503-41) / 50 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | ||||
| Approval Date: | Aug 7, 2015 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | ||||
| Approval Date: | Feb 1, 2021 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 3GM BASE/150ML (EQ 20MG BASE/ML) | ||||
| Approval Date: | May 31, 2024 | TE: | RLD: | Yes | |||||
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