Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213702

ZEPZELCA (LURBINECTEDIN)
4MG/VIAL
Marketing Status: Prescription
Active Ingredient: LURBINECTEDIN
Proprietary Name: ZEPZELCA
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 4MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213702
Product Number: 001
Approval Date: Jun 15, 2020
Applicant Holder Full Name: JAZZ PHARMACEUTICALS IRELAND LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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