Visitor Monitoring Drug History: SALAGEN
 
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: SALAGEN
FDA Application No: (NDA) 020237
Active Ingredient(s): PILOCARPINE HYDROCHLORIDE
Company: MGI PHARMA INC
 
Label History
 
View the label approved on April 28, 2003 for SALAGEN, (NDA) 020237


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
4/18/2003 012Control Supplement Letter
Label
Review 
9/4/2002 011Control Supplement  
2/4/2000 010Manufacturing Change or Addition  
6/10/2002 009Labeling Revision Letter
Label 
6/10/2002 008Labeling Revision Letter
Label 
2/11/1998 007New or Modified Indication Letter
Review 
3/11/1997 006Labeling Revision  
9/27/1996 005Labeling Revision  
11/9/1995 004Control Supplement Letter 
11/9/1995 003Control Supplement  
11/9/1995 002Control Supplement Letter 
4/18/1996 001Control Supplement  
3/22/1994 000Approval  
 
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