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Side effects include myelosuppression, hepatotoxicity, fatigue, GI distress, and CNS disturbance (23,24)

This statute states it is not an act of infringement to make, use, or sell a patented invention solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs

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If the drug administered is comprised of more than one ingredient (i.e., is a compound or the same drug with different strengths), represent each NDC on a claim line with the appropriate drug code