FdaApplication
NDA 050218
Identifiers
- fda_app_no: NDA050218
Properties
| Property | Value |
|---|---|
| applicant_name | MONARCH PHARMACEUTICALS LLC |
| application_type | NDA |
| approval_date | 1985-08-09 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CORTISPORIN | HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL |
1 product