Drugs
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Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride)
Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence. Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
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Related Information
- FDA Talk Paper
10/8/2002 - Questions and Answers about Subutex and Suboxone (buprenorphine)
- Buprenorphine Drug Label (2002) (PDF - 481KB)
- Buprenorphine Patient Leaflet (2002) (PDF - 223KB)
- Buprenorphine Information for Physicians (2002) (PDF - 322KB)
- Buprenorphine Information for Pharmacists (2002) (PDF - 230KB)
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Labeling and Regulatory History from Drugs@FDA
Includes current labeling
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