Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020011

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LUPRON DEPOT (LEUPROLIDE ACETATE)
3.75MG
Marketing Status: Prescription

Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: LUPRON DEPOT
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3.75MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020011
Product Number: 002
Approval Date: Oct 26, 1995
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LUPRON DEPOT (LEUPROLIDE ACETATE)
3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020011
Product Number: 001
Approval Date: Oct 22, 1990
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information