FdaApplication
NDA 017598
Identifiers
- fda_app_no: NDA017598
Properties
| Property | Value |
|---|---|
| applicant_name | MONARCH PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 1986-02-12 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SEPTRA | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL |
| SEPTRA GRAPE | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL |
2 products