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          Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing IronSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
					Guidance for Industry
		
		July 1997


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-1997-D-0489
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance describes how manufacturers and packagers affected by the final rule that published in the Federal Register (62 FR 2218) on January 15, 1997, requiring label warning statements and unit-dose packaging for solid oral drug products that contain 30 milligrams (mg) or more of iron per dosage unit, may meet stability and expiration dating requirements.


 
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						All written comments should be identified with this document's docket number: FDA-1997-D-0489.

                                                                                  Content current as of:
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