Product Details for NDA 020733
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020733
Product Number: 001
Approval Date: Oct 8, 2002
Applicant Holder Full Name: INDIVIOR INC
Marketing Status: Discontinued
Patent and Exclusivity Information
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020733
Product Number: 001
Approval Date: Oct 8, 2002
Applicant Holder Full Name: INDIVIOR INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020733
Product Number: 002
Approval Date: Oct 8, 2002
Applicant Holder Full Name: INDIVIOR INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SUBOXONE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020733
Product Number: 002
Approval Date: Oct 8, 2002
Applicant Holder Full Name: INDIVIOR INC
Marketing Status: Discontinued
Patent and Exclusivity Information