Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208843
Company: ADDMEDICA SAS
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 No
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 PRIORITY; 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
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-Medication Guide, Labeling-Container/Carton Labels, 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
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208843s001lbl.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-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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