Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020517

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LUPRON DEPOT (LEUPROLIDE ACETATE)
22.5MG/VIAL Marketing Status: Prescription

Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 22.5MG/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020517
Product Number: 001
Approval Date: Dec 22, 1995
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LUPRON DEPOT (LEUPROLIDE ACETATE)
30MG/VIAL Marketing Status: Prescription

Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020517
Product Number: 002
Approval Date: May 30, 1997
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LUPRON DEPOT (LEUPROLIDE ACETATE)
45MG/VIAL Marketing Status: Prescription

Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 45MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020517
Product Number: 003
Approval Date: Jun 17, 2011
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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