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FDA approval · 2017-12-13

FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Original Application (SpecGx LLC)

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Summary

FDA approved a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product for opioid dependence. This is the Original Application (ANDA207…

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Diseases / indications

Drugs mentioned

  • Buprenorphine hydrochloride and naloxone hydrochloride dihydrate (buprenorphine hydrochloride and naloxone hydrochloride dihydrate)

Snippet

ORIG AP for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE)