Visitor Monitoring Drug History: SINEQUAN
 
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Label and Approval History

Drug Name: SINEQUAN
FDA Application No: (NDA) 017516
Active Ingredient(s): DOXEPIN HYDROCHLORIDE
Company: PFIZER
 
Label History
 
View the label approved on August 3, 2007 for SINEQUAN, (NDA) 017516


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
8/2/2007 023Labeling Revision Letter
Label 
2/18/2005 022Labeling Revision Letter 
9/30/2003 020Labeling Revision Letter 
4/10/2000 018Labeling Revision  
7/21/1994 015Manufacturing Change or Addition  
12/4/1989 014Manufacturing Change or Addition  
3/22/1988 011Labeling Revision  
9/13/1984 010Labeling Revision  
5/1/1984 009Labeling Revision  
11/30/1981 008Control Supplement  
6/8/1978 007Control Supplement  
6/30/1976 006Expiration Date Change  
3/31/1975 003Other Amendment  
9/23/1974 002Control Supplement  
3/11/1974 000Approval Other Important Information from FDA 
 
Therapeutic Equivalents
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