Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-04-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for methadone hydrochloride, a generic product manufactured by Ascend Laboratories, LLC.
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FDA approval · 2013-04-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC. This approval pertains to a supplemental change to the …
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FDA approval · 2013-04-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for methadone hydrochloride (generic methadone) under ANDA, authorizi…
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FDA approval · 2013-02-22FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis's generic buprenorphine and naloxone product under an original ANDA for the treatment of opioid use disorder.
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FDA approval · 2013-02-22FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Original Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals LLC's original application for a generic buprenorphine HCl and naloxone HCl product. This approval p…
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FDA approval · 2013-02-21FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc., resulting in modifications to an already appr…
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FDA approval · 2012-11-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC, indicating approval or modification of a generic p…
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FDA approval · 2012-08-10FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE (buprenorphine/naloxone) submitted by INDIVIOR INC. The action represents an additi…
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FDA approval · 2012-07-09FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for methadone hydrochloride, approving a generic methadone produc…
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FDA approval · 2012-07-09FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for methadone hydrochloride from Ascend Laboratories, LLC.
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FDA approval · 2012-07-09FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc., enabling the generic methadone prod…
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FDA approval · 2012-02-24FDA Approved: NALTREXONE HYDROCHLORIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' original application for a generic naltrexone hydrochloride product. The approval covers indicat…
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FDA approval · 2011-10-21FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride from VistaPharm, LLC. The approval authorizes the marketing of the gener…
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FDA approval · 2010-09-24FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Original Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a generic buprenorphine hydrochloride product under an Original Application (ANDA 090622) from PAI Holdings/PAI Pharma. This ma…
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FDA approval · 2010-08-30FDA Approved: SUBOXONE — Original Application (INDIVIOR INC.)
FDA approved Suboxone (buprenorphine/naloxone) under the original application for the treatment of opioid use disorder.
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FDA approval · 2010-03-22FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes to update the product labeling under a supplemental appr…
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FDA approval · 2009-11-09FDA Approved: METHADOSE DISPERSIBLE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadose Dispersible (methadone hydrochloride) from SpecGx LLC, authorizing the dispersible dos…
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FDA approval · 2008-01-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, enabling another generic version of the product.
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FDA approval · 2008-01-14FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2008-01-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., authorizing changes included in…
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FDA approval · 2008-01-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride (generic) submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2007-12-14FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for Methadone Hydrochloride from VistaPharm, LLC, resulting in a supplemental approval for this gene…
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FDA approval · 2007-10-26FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc.
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FDA approval · 2007-06-07FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for generic methadone hydrochloride from Hikma Pharmaceuticals USA Inc.
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FDA approval · 2007-06-07FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc., indicating approval of a generic pr…