Visitor Monitoring Drug History: OPHTHAINE
 
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Label and Approval History

Drug Name: OPHTHAINE
FDA Application No: (NDA) 008883
Active Ingredient(s): PROPARACAINE HYDROCHLORIDE
Company: APOTHECON
 
Label History
 
Labels are not available on this site for OPHTHAINE, (NDA) 008883
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
8/8/1988 014Manufacturing Change or Addition  
11/5/1986 013Control Supplement  
5/3/1984 012Package Change  
7/26/1985 011Manufacturing Change or Addition  
3/22/1983 010Control Supplement  
5/8/1982 009Practioner Draft Labeling  
10/4/1979 008Control Supplement  
8/24/1978 007Control Supplement  
9/28/1978 006Labeling Revision  
9/28/1978 005Labeling Revision  
7/1/1953 000Approval  
 
Therapeutic Equivalents
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