Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (ANDA) 083312
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: BAXTER HLTHCARE
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (ANDA) 083312
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
11/27/2002 030Labeling  
11/27/2002 029Packaging Addition  
3/12/2002 028Control Supplement  
8/9/2001 027Labeling  
11/19/1999 026Control Supplement  
2/11/1999 025Chemistry  
12/27/1994 024Chemistry  
6/16/1993 023Chemistry in Effect  
10/30/1992 022Chemistry in Effect  
3/12/1992 021Chemistry  
11/9/1990 020Labeling  
8/23/1990 019Labeling  
3/30/1990 018Chemistry  
9/19/1973 000Approval  
 
Therapeutic Equivalents
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