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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020263

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LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
7.5MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020263
Product Number: 002
Approval Date: Apr 16, 1993
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
11.25MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 11.25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020263
Product Number: 005
Approval Date: Jan 21, 1994
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
11.25MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 11.25MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020263
Product Number: 007
Approval Date: Aug 15, 2011
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
15MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020263
Product Number: 006
Approval Date: Jan 21, 1994
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
30MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020263
Product Number: 008
Approval Date: Aug 15, 2011
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
45MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020263
Product Number: 009
Approval Date: Apr 14, 2023
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020263
Product Number: 003
Approval Date: Apr 16, 1993
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LUPRON DEPOT-PED KIT (LEUPROLIDE ACETATE)
7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT-PED KIT
Dosage Form; Route of Administration: POWDER; INTRAMUSCULAR
Strength: 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020263
Product Number: 004
Approval Date: Apr 16, 1993
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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