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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209449
Company: CYCLE

Products on NDA 209449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITYR	NITISINONE	2MG	TABLET;ORAL	Prescription	None	Yes	No
NITYR	NITISINONE	5MG	TABLET;ORAL	Prescription	None	Yes	No
NITYR	NITISINONE	10MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209449s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209449Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209449Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2024	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209449s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209449Orig1s017ltr.pdf
11/05/2018	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209449s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209449Orig1s006ltr.pdf
09/02/2020	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209449s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209449Orig1s005ltr.pdf

Labels for NDA 209449

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2024	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209449s017lbl.pdf
09/02/2020	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209449s005lbl.pdf
11/05/2018	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209449s006lbl.pdf
07/26/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209449s000lbl.pdf

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