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DIFLUCAN(Fluconazole for Oral Suspension) (三十三)
2016-04-09 10:53:40 来源: 作者: 【 】 浏览:13118次 评论:0
ient/Active Moiety
Ingredient Name Basis of Strength Strength
fluconazole (fluconazole)  fluconazole 2 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-3436-26 6 CONTAINER In 1 CARTON contains a CONTAINER
1  200 mL In 1 CONTAINER This package is contained within the CARTON (0049-3436-26)
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019950 01/29/1990 

DIFLUCAN 
fluconazole   solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-3437
Route of Administration INTRAVENOUS DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluconazole (fluconazole)  fluconazole 2 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
dextrose  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-3437-26 6 CONTAINER In 1 CARTON contains a CONTAINER
1  100 mL In 1 CONTAINER This package is contained within the CARTON (0049-3437-26)
 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019950 01/29/1990 

DIFLUCAN 
fluconazole   solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0049-3438
Route of Administration INTRAVENOUS DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluconazole (fluconazole)  fluconazole 2 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
dextrose  
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 0049-3438-26 6 CONTAINER In 1 CARTON contains a CONTAINER
1  200 mL In 1 CONTAINER This package is contained within the CARTON (0049-3438-26)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019950 01/29/1990 
Labeler - Roerig (829076996) 
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals  896090987 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Pfizer Limited  519804574 API MANUFACTURE
Establishment
Name Address ID/

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