buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Drug Details
- Generic Name
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Brand Names
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Application Number
- ANDA203326
- Sponsor
- Major Pharmaceuticals
- NDC Codes
- 10
- Dosage Forms
- TABLET
- Routes
- SUBLINGUAL
- Active Ingredients
- BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE DIHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ( ) Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( )