drug monograph

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drug monograph2016-11-29T01:24:06+00:00

drug monograph 


A document produced by the FDA*, which specifies the ingredients and composition a particular prescription drug may contain, how it may be prescribed, directions for its use, warnings on potential adverse effects and other relevant information.

*The US Food and Drug Administration. Once a drug monograph is released, any company that meets the drug’s monograph requirements may produce and market the drug under its own name without seeking special approval from the FDA, as long as there are no current applicable patents on the drug’s formula.  

Synonym Monograph 

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