Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019764  

Part 2 of 2
BACTERIOSTATIC WATER 
bacteriostatic water   injection
 
Product Information
NDC Product Code (Source) 44087-8006
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
 
Inactive Ingredients
Ingredient Name Strength
WATER 1 mL  in 10 mL
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1 44087-8006-0 10 mL In 1 VIAL, GLASS None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019764  
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019764 10/08/1996 

SAIZEN 
somatropin   kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 44087-1088
 
Packaging
# NDC Package Description Multilevel Packaging
1 44087-1088-1 1 KIT In 1 CARTON None
 
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS    2 mL
Part 2 1 VIAL, GLASS    10 mL
 
Part 1 of 2
SAIZEN 
somatropin   injection, powder, lyophilized, for solution
 
Product Information

Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SOMATROPIN (SOMATROPIN)  SOMATROPIN 8.8 mg  in 2 mL
 
Inactive Ingredients
Ingredient Name Strength
SUCROSE 60.2 mg  in 2 mL
PHOSPHORIC ACID 2.05 mg  in 2 mL
 
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
 
Packaging
# NDC Package Description Multilevel Packaging
1  2 mL In 1 VIAL, GLASS None
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019764  

 
Part 2 of 2
BACTERIOSTATIC WATER 
bacteriostatic water   injection
 
Product Information

Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule      
 
Active Ingredient/Active Moiet