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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021306


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NDA 021306 describes BUTRANS, which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from two suppliers. Additional details are available on the BUTRANS profile page.

The generic ingredient in BUTRANS is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 021306
Tradename:BUTRANS
Applicant:Purdue Pharma Lp
Ingredient:buprenorphine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021306
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 021306
Suppliers and Packaging for NDA: 021306
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals L.P. 42858-353 42858-353-40 4 POUCH in 1 CARTON (42858-353-40) / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306 NDA AUTHORIZED GENERIC Rhodes Pharmaceuticals L.P. 42858-493 42858-493-40 4 POUCH in 1 CARTON (42858-493-40) / 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:Jun 30, 2010TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength10MCG/HR
Approval Date:Jun 30, 2010TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength20MCG/HR
Approval Date:Jun 30, 2010TE:ABRLD:Yes

Expired US Patents for NDA 021306

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 ⤷  Try a Trial ⤷  Try a Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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