Visitor Monitoring Drug History: INDERAL
 
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Label and Approval History

Drug Name: INDERAL
FDA Application No: (NDA) 016418
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
Company: WYETH PHARMS INC
 
Label History
 
View the label approved on September 7, 2007 for INDERAL, (NDA) 016418


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
9/6/2007 078Labeling Revision Letter
Label 
2/21/2007 077Labeling Revision Letter 
12/29/2006 076Labeling Revision Letter 
8/18/2004 073Labeling Revision Letter
Label 
2/6/2002 072Labeling Revision  
8/22/1999 071Labeling Revision  
11/7/1997 070Labeling Revision  
2/15/1990 069Labeling Revision  
3/30/1989 068Expiration Date Change  
5/25/1988 067Package Change  
1/20/1987 066Control Supplement  
10/9/1985 064Expiration Date Change  
2/28/1985 063Package Change  
12/20/1984 062Control Supplement  
2/25/1985 061Package Change  
5/21/1984 058Formulation Revision  
2/22/1985 057Manufacturing Change or Addition  
1/12/1984 056Control Supplement  
6/18/1985 055Control Supplement  
1/21/1983 054Labeling Revision  
1/7/1983 053Control Supplement  
11/12/1982 052Formulation Revision  
10/31/1986 051New or Modified Indication  
10/18/1982 049Labeling Revision  
10/18/1982 048General Efficacy (MarkIV)  
9/30/1983 047General Efficacy (MarkIV)  
2/8/1982 046Control Supplement  
10/15/1981 045Manufacturing Change or Addition  
10/31/1986 044New or Modified Indication  
1/26/1982 043Labeling Revision  
3/21/1983 041Manufacturing Change or Addition  
9/19/1980 039Control Supplement  
9/16/1980 038Control Supplement  
3/24/1980 037Package Change  
3/24/1980 036Formulation Revision  
10/31/1986 035New or Modified Indication  
3/7/1979 034Control Supplement  
3/21/1979 033Control Supplement  
5/3/1979 032Formulation Revision  
2/12/1979 031Control Supplement  
8/3/1978 030Package Change  
12/12/1978 029Labeling Revision  
2/14/1978 028Package Change  
4/24/1978 027Control Supplement  
4/24/1978 026Package Change  
1/17/1979 025General Efficacy (MarkIV)  
3/7/1979 024Labeling Revision  
12/8/1977 023Package Change  
11/3/1977 022Control Supplement  
9/21/1976 021Control Supplement  
8/21/1978 020Labeling Revision  
2/18/1975 016Labeling Revision  
11/13/1967 000Approval  
 
Therapeutic Equivalents
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