Medi Nuclear Corp.
ANDA suitability petition for Xenon-133 in saline containing 60 mCi or 150 mCi of radioactivity per vial approved by FDA. Reference product, New England Nuclear's Xenon-133 in saline containing up to 100 mCi per vial is no longer marketed. However, FDA determined that the product's removal from the market was not for reasons of safety or efficacy.
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