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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208627
Company: SIGA TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TPOXX TECOVIRIMAT 200MG CAPSULE;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
07/13/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208627Orig1s000ltr.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208627Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/03/2024 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208627s008,214518s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208627Orig1s008; 214518Orig1s003ltr.pdf
05/18/2022 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208627s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208627Orig1s007ltr.pdf
11/23/2021 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208627s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208627Orig1s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/03/2024 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208627s008,214518s003lbl.pdf
05/18/2022 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208627s007lbl.pdf
11/23/2021 SUPPL-6 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208627s006lbl.pdf
07/13/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf
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