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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213006

GEMTESA (VIBEGRON)
75MG
Marketing Status: Prescription
Active Ingredient: VIBEGRON
Proprietary Name: GEMTESA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 75MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213006
Product Number: 001
Approval Date: Dec 23, 2020
Applicant Holder Full Name: UROVANT SCIENCES GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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