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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208843
Company: THERAVIA

Medication Guide

Products on NDA 208843

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208843

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

Labels for NDA 208843

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

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