Visitor Monitoring Drug History: RENAGEL
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
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Label and Approval History

Drug Name: RENAGEL
FDA Application No: (NDA) 020926
Active Ingredient(s): SEVELAMER HYDROCHLORIDE
Company: GENZYME
 
Label History
 
View the label approved on October 30, 1998 for RENAGEL, (NDA) 020926


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/6/2004 006New or Modified Indication Letter 
8/8/2002 005Manufacturing Change or Addition  
3/15/2002 004Control Supplement  
10/13/2000 003Manufacturing Change or Addition  
5/5/2000 002New Dosage Regimen Letter 
10/1/1999 001Manufacturing Change or Addition  
10/30/1998 000Approval Letter
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