buprenorphine and naloxone

FDA Drug Profile — Buprenorphine and Naloxone

Drug Details

Generic Name
buprenorphine and naloxone
Brand Names
Buprenorphine and Naloxone
Application Number
ANDA212756
Sponsor
INGENUS PHARMACEUTICALS, LLC
NDC Codes
8
Dosage Forms
FILM
Routes
BUCCAL, SUBLINGUAL
Active Ingredients
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )