Application 050218
- Type
- NDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CORTISPORIN | HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | CREAM;TOPICAL | 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61570-032 | CORTISPORIN | neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-032 | CORTISPORIN | neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate | Pfizer Laboratories Div Pfizer Inc | NDA | Current |