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          ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls InformationSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
					Guidance for Industry
		
		July 2007


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2004-D-0182
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


Chemistry, manufacturing, and controls (CMC) information must be submitted to support the approval of an abbreviated new drug application (ANDA). This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms.


 
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						All written comments should be identified with this document's docket number: FDA-2004-D-0182.

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