Visitor Monitoring Drug History: NEURONTIN
 
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Label and Approval History

Drug Name: NEURONTIN
FDA Application No: (NDA) 021129
Active Ingredient(s): GABAPENTIN
Company: PARKE DAVIS
 
Label History
 
View the label approved on February 23, 2005 for NEURONTIN, (NDA) 021129


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
5/3/2006 020Labeling Revision Letter 
2/18/2005 016Labeling Revision Letter
Label 
12/19/2002 013Control Supplement  
10/24/2002 011Manufacturing Change or Addition  
8/15/2002 010Efficacy Supplement with Clinical Data to Support Letter 
1/30/2002 009Labeling Revision Letter 
1/18/2002 008Control Supplement  
4/26/2001 006Manufacturing Change or Addition  
10/12/2000 005Efficacy Supplement with Clinical Data to Support Review 
9/19/2000 004Manufacturing Change or Addition  
3/2/2000 000Approval Review 
 
Therapeutic Equivalents
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