Visitor Monitoring Drug History: GLUCOTROL XL
 
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Label and Approval History

Drug Name: GLUCOTROL XL
FDA Application No: (NDA) 020329
Active Ingredient(s): GLIPIZIDE
Company: PFIZER
 
Label History
 
View the label approved on April 1, 2002 for GLUCOTROL XL, (NDA) 020329


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
9/17/2003 015Labeling Revision Letter
Review 
10/26/2001 013Labeling Revision  
6/25/2001 012Manufacturing Change or Addition  
10/31/2000 011Control Supplement  
1/16/2001 010Manufacturing Change or Addition  
7/26/2000 009Manufacturing Change or Addition  
10/26/2000 008Manufacturing Change or Addition  
4/17/2000 007Control Supplement  
9/5/2001 006Labeling Revision  
12/15/1999 005Package Change  
11/18/1999 004Manufacturing Change or Addition  
8/10/1999 003Control Supplement Review 
4/1/2002 002Efficacy Supplement with Clinical Data to Support Letter
Label 
2/4/1998 001New or Modified Indication  
4/26/1994 000Approval  
 
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