Application 050416
- Type
- NDA
- Sponsor
- CASPER PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | CORTISPORIN | BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | OINTMENT;OPHTHALMIC | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |