Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021232
Company: SWEDISH ORPHAN
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 None Yes Yes
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
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

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 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 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 211041 NOVITIUM PHARMA
ORFADIN NITISINONE 10MG CAPSULE;ORAL Prescription Yes AB 021232 SWEDISH ORPHAN

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