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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/07/1967 | 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 |
|---|---|---|---|---|---|
| 11/28/2023 | SUPPL-58 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016295s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016295Orig1s058ltr.pdf | |
| 06/07/2023 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/016295Orig1s057Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/016295Orig1s057ltr.pdf | |
| 01/13/2022 | SUPPL-56 | Labeling-Medication Guide |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/016295Orig1s056ltr.pdf |
| 08/05/2021 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016295Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016295Orig1s055ltr.pdf | |
| 02/09/2021 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016295s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016295Orig1s054ltr.pdf | |
| 12/18/2019 | SUPPL-52 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016295Orig1s052ltr.pdf | |
| 07/22/2019 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Label for DROXIA includes a Medication Guide | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016295s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/016295Orig1s051ltr.pdf |
| 12/18/2017 | SUPPL-50 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016295Orig1s049,s050ltr.pdf | |
| 12/18/2017 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/016295Orig1s049,s050ltr.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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016295Orig1s047,s048Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016295Orig1s047,s048ltr.pdf | |
| 07/16/2015 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s046ltr.pdf | |
| 07/16/2015 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/016295s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016295Orig1s045ltr.pdf | |
| 01/26/2012 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf | |
| 01/26/2012 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016295s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016295s041,s042ltr.pdf | |
| 05/07/2010 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016295s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016295s040ltr.pdf | |
| 09/19/2006 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016295s039s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016295s039, 016295s036ltr.pdf | |
| 02/19/2004 | SUPPL-37 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16295slr037_hydrea_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16295slr037ltr.pdf | |
| 06/26/2003 | SUPPL-36 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16295se2-036_droxia_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16295se2-036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/16-295S036_Droxia.cfm | |
| 02/20/2001 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/04/2001 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16295S34ltr.pdf |
| 01/12/2000 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-29 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/25/1996 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/1996 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/09/1993 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1995 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1988 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/19/1987 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/19/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/1977 | SUPPL-8 | 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 |
|---|---|---|---|---|---|
| 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-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016295s049s050lbl.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-49 | 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 | |
| 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 |
DROXIA
There are no Therapeutic Equivalents.
HYDREA
CAPSULE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | Yes | AB | 016295 | CHEPLAPHARM |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 075143 | BARR |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 213438 | LEADING |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 075340 | PAR PHARM |
| HYDROXYUREA | HYDROXYUREA | 500MG | CAPSULE;ORAL | Prescription | No | AB | 218021 | QILU |