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Application 212080
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | GEL;OPHTHALMIC | 0.5% | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 17478-830 | Loteprednol Etabonate | Loteprednol Etabonate | Akorn | ANDA | Current |
| 17478-830 | Loteprednol Etabonate | Loteprednol Etabonate | Akorn | ANDA | Current |
| 17478-830 | Loteprednol Etabonate | Loteprednol Etabonate | Akorn, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 66718 | ORIG | 2021-03-10 |