Visitor Monitoring Drug History: OPTIRAY 240
 
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Label and Approval History

Drug Name: OPTIRAY 240
FDA Application No: (NDA) 019710
Active Ingredient(s): IOVERSOL
Company: MALLINCKRODT
 
Label History
 
Labels are not available on this site for OPTIRAY 240, (NDA) 019710
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/2/2001 027Control Supplement  
9/12/2001 026Manufacturing Change or Addition  
1/23/2001 025Package Change  
10/27/1999 024Formulation Revision  
4/16/1999 023Manufacturing Change or Addition  
3/25/1999 022Manufacturing Change or Addition  
5/23/1997 021Manufacturing Change or Addition Review 
1/13/1995 019Labeling Revision  
6/21/1995 018New or Modified Indication  
7/27/1993 017New or Modified Indication  
3/9/1993 016New or Modified Indication  
7/12/1996 013Package Change  
12/11/1992 012New or Modified Indication  
10/26/1992 011Manufacturing Change or Addition  
9/22/1993 010Manufacturing Change or Addition  
8/28/1992 009Package Change  
12/4/1992 008Control Supplement  
7/9/1992 007New or Modified Indication  
1/22/1992 005Control Supplement  
1/22/1992 004New or Modified Indication  
3/30/1990 003Control Supplement  
10/10/1989 002Package Change  
4/17/1989 001Labeling Revision  
12/30/1988 000Approval  
 
Therapeutic Equivalents
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