FdaApplication
NDA 050585
Identifiers
- fda_app_no: NDA050585
Properties
| Property | Value |
|---|---|
| applicant_name | HOFFMANN LA ROCHE INC |
| application_type | NDA |
| approval_date | 1984-12-21 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
| ROCEPHIN KIT | CEFTRIAXONE SODIUM; LIDOCAINE | EQ 1GM BASE/VIAL,N/A;N/A,1% | INJECTABLE;INJECTION |
| ROCEPHIN KIT | CEFTRIAXONE SODIUM; LIDOCAINE | EQ 500MG BASE/VIAL,N/A;N/A,1% | INJECTABLE;INJECTION |
7 products