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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204242

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ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 0.7MG BASE;EQ 0.18MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: ZUBSOLV
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.7MG BASE;EQ 0.18MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204242
Product Number: 006
Approval Date: Oct 4, 2016
Applicant Holder Full Name: OREXO US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 1.4MG BASE;EQ 0.36MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: ZUBSOLV
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 1.4MG BASE;EQ 0.36MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204242
Product Number: 001
Approval Date: Jul 3, 2013
Applicant Holder Full Name: OREXO US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 2.9MG BASE;EQ 0.71MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: ZUBSOLV
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2.9MG BASE;EQ 0.71MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204242
Product Number: 005
Approval Date: Jun 4, 2015
Applicant Holder Full Name: OREXO US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 5.7MG BASE;EQ 1.4MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: ZUBSOLV
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 5.7MG BASE;EQ 1.4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204242
Product Number: 002
Approval Date: Jul 3, 2013
Applicant Holder Full Name: OREXO US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 8.6MG BASE;EQ 2.1MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: ZUBSOLV
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 8.6MG BASE;EQ 2.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204242
Product Number: 003
Approval Date: Dec 11, 2014
Applicant Holder Full Name: OREXO US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 11.4MG BASE;EQ 2.9MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: ZUBSOLV
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 11.4MG BASE;EQ 2.9MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204242
Product Number: 004
Approval Date: Dec 11, 2014
Applicant Holder Full Name: OREXO US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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