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          ANDAs: Stability Testing of Drug Substances and ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ANDAs: Stability Testing of Drug Substances and Products
					
		
		June 2013


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2012-D-0938
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act, and the drug master files (DMFs) that support ANDAs, follow the stability recommendations provided in the International Conference on Harmonisation (ICH) stability guidances.


 
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						All written comments should be identified with this document's docket number: FDA-2012-D-0938.

                                                                                  Content current as of:
      05/06/2020
         
                  
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