Application 016885
- Type
- NDA
- Sponsor
- HRA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LYSODREN | MITOTANE | TABLET;ORAL | 500MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0015-3080 | LYSODREN | MITOTANE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0015-3080 | LYSODREN | MITOTANE | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 76336-080 | Lysodren | mitotane | HRA Pharma Rare Diseases | NDA | Current |
| 76336-080 | Lysodren | mitotane | Laboratoire HRA Pharma | NDA | Current |
| 76336-080 | Lysodren | mitotane | HRA Pharma Rare Diseases | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80047 | SUPPL | 2024-10-30 |
| 80043 | SUPPL | 2024-10-29 |
| 80042 | SUPPL | 2024-10-29 |
| 77202 | SUPPL | 2024-01-10 |
| 77200 | SUPPL | 2024-01-09 |
| 67837 | SUPPL | 2021-06-17 |
| 67828 | SUPPL | 2021-06-16 |
| 48357 | SUPPL | 2017-05-12 |
| 48335 | SUPPL | 2017-05-10 |
| 13049 | SUPPL | 2016-03-15 |
| 10932 | SUPPL | 2016-03-15 |
| 10931 | SUPPL | 2013-11-22 |
| 513 | SUPPL | 2013-11-18 |
| 13048 | SUPPL | 2009-02-13 |
| 10930 | SUPPL | 2009-02-12 |
| 20068 | SUPPL | 2009-01-12 |
| 13047 | SUPPL | 2003-07-28 |