Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012911
Company: HRA PHARMA
Company: HRA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METOPIRONE | METYRAPONE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| METOPIRONE | METYRAPONE | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/04/1961 | 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 |
|---|---|---|---|---|---|
| 07/25/2023 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012911s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/012911Orig1s039ltr.pdf | |
| 09/08/2022 | SUPPL-38 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012911s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/012911Orig1s038ltr.pdf | |
| 02/20/2020 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/012911Orig1s036ltr.pdf | |
| 10/22/2018 | SUPPL-35 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012911s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012911Orig1s035ltr.pdf | |
| 08/14/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/2013 | SUPPL-33 | Manufacturing (CMC) |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012911Orig1s033ltr.pdf | |
| 09/20/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/2010 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012911s026ltr.pdf | |
| 05/07/2004 | SUPPL-23 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12911slr023ltr.pdf |
| 04/21/1999 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1996 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/09/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/26/1992 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/10/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/29/1984 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1983 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/03/1978 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/02/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/25/2023 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/012911s039lbl.pdf | |
| 09/08/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012911s038lbl.pdf | |
| 09/08/2022 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/012911s038lbl.pdf | |
| 02/20/2020 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf | |
| 02/20/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf | |
| 10/22/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012911s035lbl.pdf | |
| 10/22/2018 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012911s035lbl.pdf | |
| 09/05/2013 | SUPPL-33 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012911Orig1s033lbl.pdf |
| 11/04/2010 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012911s026lbl.pdf |