Details for New Drug Application (NDA): 050585
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NDA 050585 describes ROCEPHIN KIT, which is a drug marketed by Hoffmann La Roche and is included in one NDA. Additional details are available on the ROCEPHIN KIT profile page.
The generic ingredient in ROCEPHIN KIT is ceftriaxone sodium; lidocaine. There are twenty-six drug master file entries for this compound. Additional details are available on the ceftriaxone sodium; lidocaine profile page.
The generic ingredient in ROCEPHIN KIT is ceftriaxone sodium; lidocaine. There are twenty-six drug master file entries for this compound. Additional details are available on the ceftriaxone sodium; lidocaine profile page.
Summary for 050585
| Tradename: | ROCEPHIN KIT |
| Applicant: | Hoffmann La Roche |
| Ingredient: | ceftriaxone sodium; lidocaine |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 21, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 21, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Strength | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 21, 1984 | TE: | RLD: | Yes | |||||
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