Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-07-07FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for buprenorphine hydrochloride and naloxone hydrochloride dihydrate from Hikma Pharmaceuticals USA …
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FDA approval · 2016-07-07FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone, a buprenorphine and naloxone product from Indivior Inc.
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FDA approval · 2016-07-07FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone (Actavis Pharma, Inc.), marking the approval of a generic product.
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FDA approval · 2016-05-20FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc. This action represents a supplemental approval relat…
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FDA approval · 2016-04-20FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride (ANDA040241) submitted by VistaPharm, LLC.
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FDA approval · 2016-04-20FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride by VistaPharm, LLC, representing an approved change to an already-ap…
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FDA approval · 2016-04-20FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved Aurolife Pharma's supplemental application for methadone hydrochloride, granting approval of a generic methadone hydrochloride …
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FDA approval · 2016-04-20FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for Methadone hydrochloride by Epic Pharma, LLC.
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FDA approval · 2016-04-20FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approves a supplemental application for methadone hydrochloride manufactured by SpecGx LLC.
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FDA approval · 2016-04-20FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc., updating an existing generic produc…
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FDA approval · 2016-04-15FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine hydrochloride and naloxone hydrochloride) submitted by Indivior.
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FDA approval · 2015-12-08FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc., approving changes to labeling and expanding its i…
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FDA approval · 2015-10-16FDA Approved: BUPRENORPHINE AND NALOXONE — Original Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved the original application for a generic buprenorphine and naloxone product for the treatment of opioid use disorder.
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FDA approval · 2015-09-22FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride, naloxone hydrochloride) from Indivior Inc., authorizing c…
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FDA approval · 2015-08-31FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Aurolife Pharma, LLC)
FDA approves the original application (ANDA) for methadone hydrochloride from Aurolife Pharma, LLC (a generic product).
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FDA approval · 2015-08-24FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for DISKETS (methadone hydrochloride) from Hikma Pharmaceuticals USA Inc. The action updates the pro…
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FDA approval · 2015-08-18FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Epic Pharma, LLC)
FDA approved the original application for methadone hydrochloride from Epic Pharma, LLC as a generic drug.
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FDA approval · 2015-08-17FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC, indicating an approved modification to an existing…
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FDA approval · 2015-07-22FDA Approved: NALTREXONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for naltrexone hydrochloride from Sun Pharmaceutical Industries, Inc., updating an existing gene…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride (generic) manufactured by VistaPharm, LLC.
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for methadone hydrochloride by Ascend Laboratories, LLC, confirming regulatory approval for chan…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, enabling the marketing of a generic methadone hydrochlo…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc., enabling a generic methadone hy…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride by Hikma Pharmaceuticals USA Inc., authorizing a change to the approved …
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FDA approval · 2015-06-23FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride, naloxone hydrochloride) submitted by INDIVIOR INC., resul…