Visitor Monitoring Drug History: LABETALOL HYDROCHLORIDE
 
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Label and Approval History

Drug Name: LABETALOL HYDROCHLORIDE
FDA Application No: (ANDA) 074787
Active Ingredient(s): LABETALOL HYDROCHLORIDE
Company: IVAX PHARMS
 
Label History
 
View the label approved on June 8, 2004 for LABETALOL HYDROCHLORIDE, (ANDA) 074787


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
8/5/2002 014Packaging Addition  
7/29/2002 013Facility Addition  
8/5/2002 012Control Supplement  
3/26/2002 011Package Change  
9/12/2001 010Packager Addition  
8/5/2002 009Supplier Addition  
12/18/2000 008Labeling  
1/28/2000 007Facility Addition  
12/18/2000 006Packaging Addition  
10/25/1999 005Chemistry  
10/25/1999 004Chemistry  
10/25/1999 003Chemistry  
10/25/1999 002Chemistry  
4/30/1999 001Labeling  
8/3/1998 000Approval Letter
Label
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