Visitor Monitoring Drug History: ACULAR
 
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: ACULAR
FDA Application No: (NDA) 019700
Active Ingredient(s): KETOROLAC TROMETHAMINE
Company: ALLERGAN
 
Label History
 
View the label approved on March 11, 2005 for ACULAR, (NDA) 019700


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
3/10/2005 024Labeling Revision Letter
Label 
3/10/2005 023Package Change Letter
Label 
4/12/2002 022Manufacturing Change or Addition  
4/15/2002 021Package Change  
12/4/2001 020Manufacturing Change or Addition  
2/8/2002 019Patient Population Altered Letter
Label 
7/16/2001 018Manufacturing Change or Addition Label 
4/12/2001 017Manufacturing Change or Addition  
10/2/2000 016Manufacturing Change or Addition  
4/27/2001 014Labeling Revision  
2/4/1998 013Control Supplement  
5/19/1998 012Control Supplement  
7/21/1997 011Manufacturing Change or Addition  
4/30/1997 009Control Supplement  
12/31/1996 007New or Modified Indication  
7/11/1996 006Control Supplement  
9/18/1996 005Control Supplement  
9/18/1996 004Labeling Revision  
9/18/1996 003New Dosage Regimen  
3/29/1996 002Control Supplement  
4/14/1994 001Manufacturing Change or Addition  
11/9/1992 000Approval  
 
Therapeutic Equivalents
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