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drug monograph

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drug monograph,
a statement that specifies the kinds and amounts of ingredients a drug or class of drugs may contain, the directions for the drug's use, the conditions in which it may be used, and the contraindications to its use.


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5x8"), the latest addition to the PDR family, contains 1,800 drug monographs based on the latest FDA- approved prescribing information, plus 100 reference tables and charts, as well as a Visual Identification Guide showing hundreds of life-sized pill images.
Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances.
A drug may also be marketed through the OTC drug monograph system (1), by which the active ingredient and dosage of a drug have been generally deemed safe and effective, and a manufacturer follows the standards set out in the monograph for the drug.
 
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