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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206586

BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.3MG BASE/ML
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.3MG BASE/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A206586
Product Number: 001
Approval Date: Jul 28, 2015
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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