Drugs
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Safety Labeling Change Orders
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Safety Labeling Change Order Letters
Advair Diskus, Advair HFA, and Serevent Diskus Safety Labeling Change Order (PDF - 92KB)
6/2/2010Aranesp Safety Labeling Change Order (PDF - 83KB)Epogen and Procrit Safety Labeling Change Order (PDF - 85KB)Propylthiouracil Safety Labeling Change Order (PDF - 30KB)Symbicort Safety Labeling Change Order (PDF - 54KB)
6/2/2010Symbyax Safety Labeling Change Order (PDF - 26KB)
7/19/2009Vasotec Safety Labeling Change Order (PDF - 317KB)
3/9/2010Zyprexa Safety Labeling Change Order (PDF - 28KB)
7/19/2009
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Related Information
- Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF - 129KB)
Guidance for Industry (4/12/2011)
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