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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021306

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BUTRANS (BUPRENORPHINE)
5MCG/HR
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BUTRANS
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 5MCG/HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021306
Product Number: 001
Approval Date: Jun 30, 2010
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
BUTRANS (BUPRENORPHINE)
7.5MCG/HR
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BUTRANS
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 7.5MCG/HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021306
Product Number: 005
Approval Date: Jun 30, 2014
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
BUTRANS (BUPRENORPHINE)
10MCG/HR
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BUTRANS
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 10MCG/HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021306
Product Number: 002
Approval Date: Jun 30, 2010
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
BUTRANS (BUPRENORPHINE)
15MCG/HR
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BUTRANS
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 15MCG/HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021306
Product Number: 004
Approval Date: Jul 25, 2013
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
BUTRANS (BUPRENORPHINE)
20MCG/HR
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE
Proprietary Name: BUTRANS
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 20MCG/HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021306
Product Number: 003
Approval Date: Jun 30, 2010
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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