Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205637

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BUNAVAIL (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 2.1MG BASE;EQ 0.3MG BASE Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUNAVAIL
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 2.1MG BASE;EQ 0.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205637
Product Number: 001
Approval Date: Jun 6, 2014
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUNAVAIL (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 4.2MG BASE;EQ 0.7MG BASE Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUNAVAIL
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 4.2MG BASE;EQ 0.7MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205637
Product Number: 002
Approval Date: Jun 6, 2014
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUNAVAIL (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 6.3MG BASE;EQ 1MG BASE Marketing Status: Prescription

Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUNAVAIL
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 6.3MG BASE;EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205637
Product Number: 003
Approval Date: Jun 6, 2014
Applicant Holder Full Name: BIODELIVERY SCIENCES INTERNATIONAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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