Details for New Drug Application (NDA): 050821
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NDA 050821 describes CEFEPIME 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 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER profile page.
The generic ingredient in CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
The generic ingredient in CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
Summary for 050821
| Tradename: | CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER |
| Applicant: | B Braun |
| Ingredient: | cefepime hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050821
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | cefepime hydrochloride | INJECTABLE;INJECTION | 050821 | NDA | B. Braun Medical Inc. | 0264-3193 | 0264-3193-11 | 24 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER |
| CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER | cefepime hydrochloride | INJECTABLE;INJECTION | 050821 | NDA | B. Braun Medical Inc. | 0264-3195 | 0264-3195-11 | 24 CONTAINER in 1 CASE (0264-3195-11) / 50 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1GM BASE/VIAL | ||||
| Approval Date: | May 6, 2010 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 2GM BASE/VIAL | ||||
| Approval Date: | May 6, 2010 | TE: | RLD: | Yes | |||||
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