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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019010

LUPRON (LEUPROLIDE ACETATE)
14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N019010
Product Number: 001
Approval Date: Apr 9, 1985
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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