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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208627
Company: SIGA TECHNOLOGIES

Products on NDA 208627

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TPOXX	TECOVIRIMAT	200MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208627

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

Labels for NDA 208627

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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