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Nubain Not Withdrawn for S&E

11/21/2008

Federal Register Notice: FDA has determined that Nubain (nalbuphine hydrochloride) injection, 10 and 20 mg/ml, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for nalbuphine hydrochloride injection, 10 and 20 mg/ml, if all other legal and regulatory requirements are met. To view this notice, click here.

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