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Last Updated: April 23, 2024

Details for New Drug Application (NDA): 210272


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NDA 210272 describes BUPRENORPHINE, which is a drug marketed by Alvogen, Amneal, Aveva, Mylan Tech Viatris, Watson Labs Teva, Am Regent, Hikma, Hospira, Par Sterile Products, Actavis Elizabeth, Barr, Ethypharm, Mylan, Rhodes Pharms, Rubicon, Sun Pharm, 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-six NDAs. It is available from five suppliers. Additional details are available on the BUPRENORPHINE profile page.

The generic ingredient in BUPRENORPHINE 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 210272
Tradename:BUPRENORPHINE
Applicant:Aveva
Ingredient:buprenorphine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210272
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 210272
Suppliers and Packaging for NDA: 210272
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 210272 ANDA INGENUS PHARMACEUTICALS, LLC 50742-372 50742-372-04 4 POUCH in 1 CARTON (50742-372-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
BUPRENORPHINE buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 210272 ANDA INGENUS PHARMACEUTICALS, LLC 50742-373 50742-373-04 4 POUCH in 1 CARTON (50742-373-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MCG/HR
Approval Date:Sep 23, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength7.5MCG/HR
Approval Date:Sep 23, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MCG/HR
Approval Date:Sep 23, 2021TE:ABRLD:No

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