Food and Drug Administration
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statementsFDA has not made a final determination about the safety or effectiveness of the product described in this document.
Bristol-Myers Squibb Company
New drug applications 21-797 and 21-798, entecavir tablets and entecavir oral solution, respectively, Bristol-Myers Squibb Co., proposed for the treatment of patients with chronic hepatitis B infection (HBV).
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