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Proper Name: Alpha-1-Proteinase Inhibitor (Human)
Manufacturer: Baxter Healthcare Corp, License #014
Indication: For augmentation therapy in patients having congenital deficiency of alpha-1-proteinase inhibitor with clinically evident emphysema.
September 22, 2005 (Corrected Approval Letter)
STN 125039/69, Fr.IV1 4 paste as an alternate starting material for the manufacture of ARALAST, as amended
March 21, 2003 Corrected Approval Letter - Aralast
STN 125039/0, indicated for augmentation therapy in patients having congenital deficiency of alpha-1-proteinase inhibitor with clinically evident emphysema.
Summary Basis of Approval - Aralast Appendix to Summary Basis of Approval - Aralast
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