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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205919
Company: NOVA LABS LTD

Products on NDA 205919

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PURIXAN	MERCAPTOPURINE	20MG/ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205919

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205919s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205919Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2024	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205919s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205919Orig1s008ltr.pdf
10/23/2024	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205919s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205919Orig1s007ltr.pdf
04/07/2020	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205919s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205919Orig1s004ltr.pdf
02/20/2018	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205919s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205919Orig1s003ltr.pdf
05/08/2017	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205919s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205919Orig1s002ltr.pdf
12/23/2014	SUPPL-1	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205919Orig1s001ltr.pdf

Labels for NDA 205919

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2024	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205919s007lbl.pdf
10/23/2024	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205919s007lbl.pdf
07/09/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205919s008lbl.pdf
04/07/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205919s004lbl.pdf
02/20/2018	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205919s003lbl.pdf
02/20/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205919s003lbl.pdf
05/08/2017	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205919s002lbl.pdf
05/08/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205919s002lbl.pdf
05/08/2017	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205919s002lbl.pdf
04/28/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205919s000lbl.pdf

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