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Approval History, Letters, Reviews and Related Documents - ATryn

Proper Name: Antithrombin (Recombinant)
Tradename: ATryn
Manufacturer: GTC Biotherapeutics, Inc., License # 1794
STN:125284/0
Approval Date: February 6, 2009


Approval information/letter/labeling

Memorandum/Reviews

Administrative Documents

 

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448