Application 050168
- Type
- NDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | CORTISPORIN | BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | OINTMENT;TOPICAL | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 61570-031 | CORTISPORIN | neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 61570-031 | CORTISPORIN | neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone | Pfizer Laboratories Div Pfizer Inc | NDA | Current |