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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213150

FENSOLVI KIT (LEUPROLIDE ACETATE)
45MG
Marketing Status: Prescription
Active Ingredient: LEUPROLIDE ACETATE
Proprietary Name: FENSOLVI KIT
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213150
Product Number: 001
Approval Date: May 1, 2020
Applicant Holder Full Name: TOLMAR INTERNATIONAL LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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