Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208843
Company: THERAVIA
Company: THERAVIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SIKLOS | HYDROXYUREA | 100MG | TABLET;ORAL | Prescription | None | Yes | No |
SIKLOS | HYDROXYUREA | 1GM | 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 |
---|---|---|---|---|---|---|---|
12/21/2017 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208843Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208843Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/28/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208843s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208843Orig1s004ltr.pdf | |
12/07/2021 | SUPPL-3 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208843s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208843Orig1s003ltr.pdf | |
05/22/2019 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208843s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208843Orig1s002ltr.pdf | |
12/12/2018 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208843s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208843Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/28/2023 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208843s004lbl.pdf | |
11/28/2023 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208843s004lbl.pdf | |
12/07/2021 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208843s003lbl.pdf | |
05/22/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208843s002lbl.pdf | |
12/12/2018 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208843s001lbl.pdf | |
12/12/2018 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208843s001lbl.pdf | |
12/12/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208843s001lbl.pdf | |
12/21/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208843s000lbl.pdf |