Application 208219
- Type
- NDA
- Sponsor
- BAUSCH AND LOMB INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOTEMAX SM | LOTEPREDNOL ETABONATE | GEL;OPHTHALMIC | 0.38% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24208-507 | Lotemax SM | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-507 | Lotemax SM | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-507 | Lotemax SM | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 60216 | ORIG | 2019-10-03 |
| 57904 | ORIG | 2019-03-05 |
| 57873 | ORIG | 2019-03-01 |