Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207932

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BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.075MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.075MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207932
Product Number: 001
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.15MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207932
Product Number: 002
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.3MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207932
Product Number: 003
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.45MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.45MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207932
Product Number: 004
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.6MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207932
Product Number: 005
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.75MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207932
Product Number: 006
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
EQ 0.9MG BASE
Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE
Proprietary Name: BELBUCA
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.9MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207932
Product Number: 007
Approval Date: Oct 23, 2015
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information