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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215383

WELIREG (BELZUTIFAN)
40MG
Marketing Status: Prescription
Active Ingredient: BELZUTIFAN
Proprietary Name: WELIREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215383
Product Number: 001
Approval Date: Aug 13, 2021
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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