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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 219302


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NDA 219302 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Am Regent, Hikma, Hospira, Ph Health, Somerset Theraps Llc, Actavis Elizabeth, Barr, Ethypharm, Pharmobedient, Rhodes Pharms, Rubicon Research, Sun Pharm, Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Wes Pharma Inc, and is included in thirty-one NDAs. It is available from nineteen suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE profile page.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 219302
Tradename:BUPRENORPHINE HYDROCHLORIDE
Applicant:Somerset Theraps Llc
Ingredient:buprenorphine hydrochloride
Patents:0
Pharmacology for NDA: 219302
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 219302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 219302 ANDA Somerset Therapeutics, LLC 70069-027 70069-027-05 5 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.3MG BASE/ML
Approval Date:Jan 30, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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