arketing Start Date Marketing End Date
NDA NDA021488 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 258.5mg in0.5mL
POLY(LACTIC-CO-GLYCOLIC ACID) (75/25, 0.23-0.26 DL/G INHERENT VISCOSITY) 211.5mg in0.5mL
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 Marketing Start Date Marketing End Date
NDA NDA021488 01/23/2002
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021488 01/23/2002
ELIGARD
leuprolide acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-0605
Packaging
# NDC Package Description Multilevel Packaging
1 0024-0605-45 1KITIn1CARTON None
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
Part1 1SYRINGE 0.375mL
Part2 1SYRINGE 0.375mL
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 45mg 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 NDA021731 01/23/2002
Part 2of2
ATRIGEL DELIVERY SYSTEM
1-methyl-2-pyrrolidinone and poly(lactic-co-glycolic acid) (85/15, 0.25-0.27 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 165mg in0.375mL
POLY(LACTIC-CO-GLYCOLIC ACID) (85/15, 0.25-0.27 DL/G INHERENT VISCOSITY) 165mg in0.375mL
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Mult
