FdaApplication
NDA 050406
Identifiers
- fda_app_no: NDA050406
Properties
| Property | Value |
|---|---|
| applicant_name | PRAGMA PHARMACEUTICALS LLC |
| application_type | NDA |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| KEFLEX | CEPHALEXIN | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION;ORAL |
| KEFLEX | CEPHALEXIN | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION;ORAL |
| KEFLEX | CEPHALEXIN | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION;ORAL |
3 products