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 |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/012911s036lbl.pdf | |
| 02/20/2020 | SUPPL-36 | Labeling-Container/Carton Labels | 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 |