Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-07-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC (ANDA 040517). The action represents approval of…
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FDA approval · 2014-07-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental ANDA for Ascend Laboratories' methadone hydrochloride, a generic opioid product.
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FDA approval · 2014-06-27FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a generic combination product of buprenorphine hydrochloride and naloxone hydrochloride dihydrate from Hikma for opioid use dis…
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FDA approval · 2014-06-05FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine/naloxone) from Indivior, related to its use for opioid use disorder.
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FDA approval · 2014-06-02FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for METHADOSE (methadone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2014-05-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for the buprenorphine and naloxone combination from Actavis Pharma, Inc.
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FDA approval · 2014-04-28FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine/naloxone) from Indivior Inc., updating the regulatory status for the…
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FDA approval · 2014-04-18FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application from Amneal Pharmaceuticals LLC for a generic Buprenorphine HCl and Naloxone HCl product. It is indi…
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FDA approval · 2014-04-17FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, Inc.
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FDA approval · 2014-04-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by VistaPharm, LLC.
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FDA approval · 2014-04-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., approving a generic version of this…
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FDA approval · 2014-04-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2014-03-12FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine hydrochloride, naloxone hydrochloride) submitted by Indivior Inc.
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FDA approval · 2014-01-14FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) from Orexo US, Inc.
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FDA approval · 2013-11-22FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine/naloxone) by Indivior Inc.
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FDA approval · 2013-09-19FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for DISKETS (methadone hydrochloride) from Hikma Pharmaceuticals USA Inc.
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FDA approval · 2013-09-04FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Buprenorphine HCl and Naloxone HCl from Amneal Pharmaceuticals LLC. This represents an additiona…
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FDA approval · 2013-09-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved Actavis's supplemental application for buprenorphine and naloxone, a generic opioid dependence treatment.
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FDA approval · 2013-09-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for buprenorphine hydrochloride submitted by PAI Holdings (dba Pharmaceutical Associates, Inc. a…
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FDA approval · 2013-09-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) submitted by Orexo US, Inc.
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FDA approval · 2013-09-04FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for buprenorphine, a generic opioid medication. This approval covers …
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FDA approval · 2013-08-08FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE (buprenorphine hydrochloride/naloxone hydrochloride) submitted by Indivior Inc.
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FDA approval · 2013-07-03FDA Approved: ZUBSOLV — Original Application (Orexo US, Inc.)
FDA approved ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) from Orexo US, Inc. under its Original Application (NDA204242)…
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FDA approval · 2013-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for methadone hydrochloride from Mylan Institutional LLC, resulting in updated labeling/manufact…
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FDA approval · 2013-04-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride manufactured by VistaPharm, LLC.