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FDA label_change · 2015-08-10

FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)

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Summary

FDA approved a supplemental application for ZUBSOLV, resulting in labeling changes for the buprenorphine/naloxone product from Orexo US, Inc.

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Diseases / indications

Drugs mentioned

  • ZUBSOLV (Buprenorphine hydrochloride and naloxone hydrochloride)

Snippet

SUPPL AP for ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE)