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          Orally Disintegrating TabletsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Orally Disintegrating Tablets
					Guidance for Industry
		
		December 2008


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2007-D-0365
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance provides pharmaceutical manufacturers of new and generic drug products with an Agency perspective on the definition of an orally disintegrating tablet (ODT)—which is a different dosage form than, for example, a chewable tablet or a tablet that should be swallowed whole with liquid—and also provides recommendations to applicants who would like to designate proposed products as ODTs.


 
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						All written comments should be identified with this document's docket number: FDA-2007-D-0365.

                                                                                  Content current as of:
      08/24/2018
         
                  
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