FDA Approval Activities for this Drug… Orfadin (Nitisinone) Capsules, Swedish Orphan, (R&R Registration is the U.S. Agent NDA 21-232 1/18/02 2/5/02 2/5/02 2/28/02 Orfadin Indications: An adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia tyep 1. Back to this API's Main Page.

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