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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207490


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NDA 207490 describes BUPRENORPHINE, which is a drug marketed by Alvogen, Amneal, Difgen Pharms, Mylan Tech Viatris, Watson Labs Teva, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, 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 207490
Tradename:BUPRENORPHINE
Applicant:Alvogen
Ingredient:buprenorphine
Patents:0
Pharmacology for NDA: 207490
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 207490
Suppliers and Packaging for NDA: 207490
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 207490 ANDA Alvogen Inc. 47781-406 47781-406-04 4 POUCH in 1 CARTON (47781-406-04) / 1 PATCH in 1 POUCH (47781-406-11) / 168 h in 1 PATCH
BUPRENORPHINE buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 207490 ANDA Alvogen Inc. 47781-407 47781-407-04 4 POUCH in 1 CARTON (47781-407-04) / 1 PATCH in 1 POUCH (47781-407-11) / 168 h in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength5MCG/HR
Approval Date:May 17, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MCG/HR
Approval Date:May 17, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength15MCG/HR
Approval Date:May 17, 2022TE:ABRLD:No

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