FdaApplication
NDA 050588
Identifiers
- fda_app_no: NDA050588
Properties
| Property | Value |
|---|---|
| applicant_name | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC |
| application_type | NDA |
| approval_date | 1985-12-27 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CEFOTAN | CEFOTETAN DISODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CEFOTAN | CEFOTETAN DISODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
| CEFOTAN | CEFOTETAN DISODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION |
3 products