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

Pharmacology for NDA: 021306

Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for 021306

Analgesics, Opioid
Narcotic Antagonists
Narcotics

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:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	5MCG/HR
Approval Date:	Jun 30, 2010	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	10MCG/HR
Approval Date:	Jun 30, 2010	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	20MCG/HR
Approval Date:	Jun 30, 2010	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021306

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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	RE41571	⤷ Subscribe
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	6,264,980	⤷ Subscribe
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	5,968,547	⤷ Subscribe
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	6,264,980	⤷ Subscribe
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	RE41408	⤷ Subscribe
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