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Product Approval Information - Licensing Action

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Proper name: Alpha-1-Proteinase Inhibitor (Human)
Tradename: Aralast
Manufacturer: Alpha Therapeutic Corp, Los Angeles, CA License #0744
Indication for Use: For augmentation therapy in patients having congenital deficiency of alpha-1-proteinase inhibitor with clinically evident emphysema
Approval Date: 12/23/2002
Type of submission: Biologics license application

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Approval Letter - (Text)

Label - (PDF), (Text)

Summary Basis of Approval - (PDF), (Text)

Appendix - (PDF Part 1), (PDF Part 2), (Text)

 

Updated August 27, 2003
 
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