Application 200738
- Type
- NDA
- Sponsor
- BAUSCH AND LOMB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOTEMAX | LOTEPREDNOL ETABONATE | OINTMENT;OPHTHALMIC | 0.5% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24208-443 | Lotemax | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-443 | Lotemax | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-443 | Lotemax | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-443 | Lotemax | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-443 | Lotemax | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |