U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 020517

Expand all

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
Back to Top