Visitor Monitoring Drug History: PROMETHAZINE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: PROMETHAZINE HYDROCHLORIDE
FDA Application No: (ANDA) 084591
Active Ingredient(s): PROMETHAZINE HYDROCHLORIDE
Company: WATSON LABS
 
Label History
 
Labels are not available on this site for PROMETHAZINE HYDROCHLORIDE, (ANDA) 084591
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/9/1999 085Chemistry  
2/19/1999 083Microbiology  
2/2/1999 082Microbiology  
12/4/1996 081Microbiology  
12/3/1993 080Chemistry in Effect  
9/28/1990 079Labeling in Effect  
2/25/1993 078Chemistry  
3/28/1990 077Labeling  
9/22/1989 076Labeling in Effect  
8/14/1989 075SBA  
2/28/1989 075Chemistry  
1/25/1989 074SBA  
2/28/1989 074Chemistry  
11/18/1988 073Chemistry  
11/18/1988 072Chemistry  
7/17/1986 068Chemistry  
1/12/1983 066Chemistry  
6/14/1982 065Chemistry  
9/15/1978 000Approval  
 
Therapeutic Equivalents
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