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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021232
Company: SWEDISH ORPHAN

Products on NDA 021232

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ORFADIN	NITISINONE	2MG	CAPSULE;ORAL	Prescription	AB	Yes	No
ORFADIN	NITISINONE	5MG	CAPSULE;ORAL	Prescription	AB	Yes	No
ORFADIN	NITISINONE	10MG	CAPSULE;ORAL	Prescription	AB	Yes	No
ORFADIN	NITISINONE	20MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021232

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2002	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21232lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21232ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-232_Orfadin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2019	SUPPL-23	Labeling-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; 206356Orig1s006ltr.pdf
09/01/2017	SUPPL-20	Efficacy	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021232Orig1s020ltr.pdf
02/28/2017	SUPPL-19	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s019lbl.pdf
06/13/2016	SUPPL-17	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021232s017lbl.pdf
06/05/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/27/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/30/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
05/21/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021232s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021232Orig1s013ltr.pdf
06/21/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/02/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
02/13/2013	SUPPL-10	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021232s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021232Orig1s010ltr.pdf
01/25/2010	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021232s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021232s008ltr.pdf

Labels for NDA 021232

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/17/2019	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021232s023,206356s006lbl.pdf
09/01/2017	SUPPL-20	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s020lbl.pdf
02/28/2017	SUPPL-19	Manufacturing (CMC)-Expiration Date	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021232s019lbl.pdf
06/13/2016	SUPPL-17	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021232s017lbl.pdf
05/21/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021232s013lbl.pdf
02/13/2013	SUPPL-10	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021232s010lbl.pdf
01/25/2010	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021232s008lbl.pdf
01/18/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21232lbl.pdf

Therapeutic Equivalents for NDA 021232

ORFADIN

CAPSULE;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
NITISINONE	NITISINONE	2MG	CAPSULE;ORAL	Prescription	No	AB	211041	NOVITIUM PHARMA
ORFADIN	NITISINONE	2MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
NITISINONE	NITISINONE	5MG	CAPSULE;ORAL	Prescription	No	AB	211041	NOVITIUM PHARMA
ORFADIN	NITISINONE	5MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
NITISINONE	NITISINONE	10MG	CAPSULE;ORAL	Prescription	No	AB	211041	NOVITIUM PHARMA
ORFADIN	NITISINONE	10MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NITISINONE	NITISINONE	20MG	CAPSULE;ORAL	Prescription	No	AB	216201	ETON
NITISINONE	NITISINONE	20MG	CAPSULE;ORAL	Prescription	No	AB	212390	MEDUNIK
ORFADIN	NITISINONE	20MG	CAPSULE;ORAL	Prescription	Yes	AB	021232	SWEDISH ORPHAN

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