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In the April 22, 2015, Federal Register, FDA determined, in response to a citizen petition, that oxytocin in dextrose 5% injection products were not withdrawn from sale for reasons of safety or effectiveness.
United StatesFood, Drugs, Healthcare, Life Sciences
In the April 22, 2015, Federal Register, FDA
determined, in response to a citizen petition, that oxytocin in
dextrose 5% injection products were not withdrawn from sale for
reasons of safety or effectiveness. This determination allows FDA
to approve an abbreviated new drug application ("ANDA")
for these oxytocin drug products, if all other legal and regulatory
requirements are met.
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