FdaApplication
NDA 050479
Identifiers
- fda_app_no: NDA050479
Properties
| Property | Value |
|---|---|
| applicant_name | MONARCH PHARMACEUTICALS LLC |
| application_type | NDA |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CORTISPORIN | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS;OTIC |
1 product