Visitor Monitoring Drug History: OSMITROL 10% IN WATER
 
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Label and Approval History

Drug Name: OSMITROL 10% IN WATER
FDA Application No: (NDA) 013684
Active Ingredient(s): MANNITOL
Company: BAXTER HLTHCARE
 
Label History
 
View the label approved on September 7, 2005 for OSMITROL 10 IN WATER, (NDA) 013684


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
8/26/2005 092Supplement Letter
Label 
6/9/2005 091Labeling Revision Letter
Label 
1/16/2002 087Control Supplement  
8/14/2001 086Manufacturing Change or Addition  
11/24/1999 085Manufacturing Change or Addition  
4/29/1997 084Package Change  
2/18/1994 083Control Supplement  
9/30/1994 082Control Supplement  
6/1/1994 081Control Supplement  
4/29/1991 079Control Supplement  
3/26/1991 078Control Supplement  
2/15/1991 077Control Supplement  
7/26/1989 076Control Supplement  
7/25/1987 075Package Change  
5/28/1987 074Control Supplement  
4/15/1985 071Control Supplement  
6/13/1985 070Control Supplement  
9/22/1984 069Control Supplement  
2/28/1984 068Control Supplement  
7/11/1983 067Labeling Revision  
8/28/1985 065Control Supplement  
8/28/1985 064Control Supplement  
3/16/1984 063Control Supplement  
1/24/1985 062Control Supplement  
4/8/1982 060Labeling Revision  
2/16/1982 059Control Supplement  
11/20/1981 058Control Supplement  
6/3/1982 056Control Supplement  
11/22/1982 055Practioner Draft Labeling  
4/16/1982 054Control Supplement  
8/26/1981 053Labeling Revision  
11/22/1982 051Labeling Revision  
11/22/1982 050Control Supplement  
6/29/1981 049Control Supplement  
1/21/1981 048Control Supplement  
7/31/1980 047Control Supplement  
9/8/1981 046Labeling Revision  
9/8/1981 045Control Supplement  
9/8/1981 044Labeling Revision  
9/8/1981 043Control Supplement  
4/16/1981 042Control Supplement  
6/18/1980 041Control Supplement  
5/30/1980 040Control Supplement  
8/7/1980 039Control Supplement  
6/28/1980 037Control Supplement  
8/2/1979 036Control Supplement  
10/20/1978 034Control Supplement  
8/7/1978 033Control Supplement  
3/22/1978 031Control Supplement  
2/25/1980 030Control Supplement  
6/20/1978 029Control Supplement  
3/24/1978 028Control Supplement  
2/28/1978 027Control Supplement  
12/14/1977 026Control Supplement  
8/7/1979 025Labeling Revision  
4/25/1979 024Manufacturing Change or Addition  
8/30/1977 023Labeling Revision  
2/7/1977 022Package Change  
10/7/1976 021Control Supplement  
7/13/1976 020Final Printed Labeling - MarkIV  
4/8/1977 018Control Supplement  
6/17/1976 017Control Supplement  
7/1/1976 015Control Supplement  
1/5/1976 014Control Supplement  
7/29/1975 013Control Supplement  
9/17/1975 012Control Supplement  
6/16/1975 011Control Supplement  
9/25/1975 010Control Supplement  
7/10/1975 009Control Supplement  
11/11/1974 008Supplement  
6/8/1964 000Approval  
 
Therapeutic Equivalents
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