Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022410

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SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 2MG BASE;EQ 0.5MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 2MG BASE;EQ 0.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022410
Product Number: 001
Approval Date: Aug 30, 2010
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 4MG BASE;EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 4MG BASE;EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022410
Product Number: 003
Approval Date: Aug 10, 2012
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 8MG BASE;EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 8MG BASE;EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022410
Product Number: 002
Approval Date: Aug 30, 2010
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 12MG BASE;EQ 3MG BASE
Marketing Status: Prescription
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: FILM; BUCCAL, SUBLINGUAL
Strength: EQ 12MG BASE;EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022410
Product Number: 004
Approval Date: Aug 10, 2012
Applicant Holder Full Name: INDIVIOR INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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