FdaApplication
NDA 050558
Identifiers
- fda_app_no: NDA050558
Properties
| Property | Value |
|---|---|
| applicant_name | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC |
| application_type | NDA |
| approval_date | 1983-10-19 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZINACEF | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| ZINACEF | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS |
| ZINACEF | CEFUROXIME SODIUM | EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
3 products