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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206356
Company: SWEDISH ORPHAN

Summary Review

Products on NDA 206356

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORFADIN	NITISINONE	4MG/ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206356

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/2016	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206356Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206356Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206356Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2019	SUPPL-6	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021232s023,206356s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021232Orig1s023;%20206356Orig1s006ltr.pdf
06/16/2017	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/01/2017	SUPPL-3	Efficacy	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206356s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206356Orig1s003ltr.pdf
08/30/2016	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206356Orig1s002ltr.pdf

Labels for NDA 206356

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2019	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021232s023,206356s006lbl.pdf
09/01/2017	SUPPL-3	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206356s003lbl.pdf
08/30/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s002lbl.pdf
04/22/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206356s000lbl.pdf

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