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          Orange Book Questions and Answers Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Orange Book Questions and Answers Guidance for Industry
					Guidance for Industry
		
		July 2022


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2020-D-1068
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended to assist interested parties (including prospective drug product applicants, drug product applicants, and approved application holders) in utilizing the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). This guidance provides answers to commonly asked questions that we have received from these interested parties regarding the Orange Book.


 
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						All written comments should be identified with this document's docket number: FDA-2020-D-1068.

                                                                                  Content current as of:
      07/22/2022
         
                  
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