Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016885
Company: HRA PHARMA
Company: HRA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LYSODREN | MITOTANE | 500MG | TABLET;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/08/1970 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/09/2024 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016885Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016885Orig1s032ltr.pdf | |
| 06/15/2021 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016885s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016885Orig1s029ltr.pdf | |
| 05/09/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016885s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016885Orig1s027ltr.pdf | |
| 03/11/2016 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016885Orig1s026ltr.pdf | |
| 11/15/2013 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/016885Orig1s025ltr.pdf | |
| 02/10/2009 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016885s023ltr.pdf | |
| 07/10/2003 | SUPPL-22 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16885slr022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/016885_S022_Lysodren.pdf |
| 03/29/1999 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/04/1997 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/08/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1987 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/02/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/21/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/06/1985 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1985 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/1978 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 12/24/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/09/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016885Orig1s032lbl.pdf | |
| 06/15/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016885s029lbl.pdf | |
| 05/09/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016885s027lbl.pdf | |
| 03/11/2016 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016885s026lbl.pdf | |
| 11/15/2013 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016885s025lbl.pdf | |
| 02/10/2009 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016885s023lbl.pdf |