Application 202872
- Type
- NDA
- Sponsor
- BAUSCH AND LOMB INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOTEMAX | LOTEPREDNOL ETABONATE | GEL;OPHTHALMIC | 0.5% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24208-503 | LOTEMAX | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-503 | LOTEMAX | loteprednol etabonate | Bausch & Lomb Incorporated | NDA | Current |
| 24208-508 | Loteprednol Etabonate | loteprednol etabonate | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | Current |
| 24208-508 | Loteprednol Etabonate | loteprednol etabonate | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55356 | SUPPL | 2018-08-29 |
| 54944 | SUPPL | 2018-07-23 |
| 44869 | ORIG | 2012-12-04 |
| 22902 | ORIG | 2012-12-04 |
| 32328 | ORIG | 2012-10-03 |
| 19393 | ORIG | 2012-10-01 |
| 63123 | SUPPL | 1900-01-01 |
| 63122 | SUPPL | 1900-01-01 |
| 63121 | SUPPL | 1900-01-01 |