Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016295
Company: CHEPLAPHARM
Company: CHEPLAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DROXIA | HYDROXYUREA | 200MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| DROXIA | HYDROXYUREA | 300MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| DROXIA | HYDROXYUREA | 400MG | CAPSULE;ORAL | Prescription | None | Yes | No |
| HYDREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/20/2024 | SUPPL-59 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016295Orig1s059lbl.pdf | |
| 11/28/2023 | SUPPL-58 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016295s058lbl.pdf | |
| 11/28/2023 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016295s058lbl.pdf | |
| 06/07/2023 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016295Orig1s057Lbl.pdf | |
| 08/05/2021 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016295Orig1s055lbl.pdf | |
| 02/09/2021 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016295s054lbl.pdf | |
| 12/18/2019 | SUPPL-52 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s052lbl.pdf | |
| 07/22/2019 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | Label for DROXIA includes a Medication Guide | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf |
| 12/18/2017 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf | |
| 12/18/2017 | SUPPL-50 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf | |
| 12/18/2017 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf | |
| 12/18/2017 | SUPPL-49 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf | |
| 03/23/2016 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf | |
| 03/23/2016 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf | |
| 07/16/2015 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf | |
| 07/16/2015 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf | |
| 01/26/2012 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf | |
| 01/26/2012 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf | |
| 05/07/2010 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf | |
| 09/19/2006 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf | |
| 02/19/2004 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf | |
| 06/26/2003 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf |