Route of Administration SUBCUTANEOUS DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
leuprolide acetate(leuprolide) leuprolide 22.5mg in0.375mL
 
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1  0.375mLIn1SYRINGE None
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021379 01/23/2002 
 
Part 2of2
ATRIGEL DELIVERY SYSTEM
1-methyl-2-pyrrolidinone and poly(lactic-co-glycolic acid) (75/25, 0.23-0.26 dl/g inherent viscosity) injection, suspension, extended release
 
Product Information

Route of Administration SUBCUTANEOUS DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
No Active Ingredients Found
 
Inactive Ingredients
Ingredient Name Strength
1-methyl-2-pyrrolidinone 193.9mg in0.375mL
POLY(LACTIC-CO-GLYCOLIC ACID) (75/25, 0.23-0.26 DL/G INHERENT VISCOSITY) 158.6mg in0.375mL
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1  0.375mLIn1SYRINGE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021379 01/23/2002

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021379 01/23/2002 

ELIGARD
leuprolide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-0610
 
Packaging
# NDC Package Description Multilevel Packaging
1 0024-0610-30 1KITIn1CARTON None
 
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1 1SYRINGE  0.5mL
Part2 1SYRINGE  0.5mL
 
Part 1of2
LEUPROLIDE ACETATE
leuprolide acetate injection, suspension, extended release
 
Product Information

Route of Administration SUBCUTANEOUS DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
leuprolide acetate(leuprolide) leuprolide 30mg in0.5mL
 
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1  0.5mLIn1SYRINGE None
 
Marketing Information
Marketing Category Application Number or Monograph Citation M