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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218139

TEZRULY (TERAZOSIN HYDROCHLORIDE)
EQ 1MG BASE/ML
Marketing Status: Prescription
Active Ingredient: TERAZOSIN HYDROCHLORIDE
Proprietary Name: TEZRULY
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 1MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218139
Product Number: 001
Approval Date: Jul 29, 2024
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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