Visitor Monitoring Drug Details: ORFADIN
 
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Drug Details

Drug Name: ORFADIN
FDA Application No: (NDA) 021232
Active Ingredient(s): NITISINONE
Company: SWEDISH ORPHAN
Original Approval or Tentative Approval Date: January 18, 2002
Chemical Type: 1 New molecular entity (NME)
Review Classification: P Priority review drug
O Orphan drug
 
There are no Therapeutic Equivalents Label Information
Approval History, Letters, Reviews and Related Documents
 
You can see the products in the same application. The table can be sorted by clicking the header columns.
 
Drug NameSort imageActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE Code
ORFADIN NITISINONE2MGCAPSULE; ORAL Prescription No None
ORFADIN NITISINONE5MGCAPSULE; ORAL Prescription No None
ORFADIN NITISINONE10MGCAPSULE; ORAL Prescription Yes None


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