Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-09-08FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA has approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) submitted by Orexo US, Inc.
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FDA approval · 2017-05-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by VistaPharm, LLC. The action represents an additional regula…
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FDA approval · 2017-05-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approves a supplemental application for methadone hydrochloride (generic) from Ascend Laboratories, LLC.
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FDA approval · 2017-05-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)
FDA approved a supplemental application for methadone hydrochloride from Epic Pharma, LLC, approving the generic formulation.
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FDA approval · 2017-05-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Methadone Hydrochloride by Hikma Pharmaceuticals USA Inc., updating the product's approved i…
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FDA approval · 2017-05-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., documenting the acceptance of a sup…
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FDA approval · 2017-05-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. to modify/update the product's appro…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, expanding its existing approval for opioid u…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental (ANDA) application for a generic buprenorphine/naloxone product from Lannett Company, Inc.
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for buprenorphine HCl and naloxone HCl by Amneal Pharmaceuticals LLC.
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FDA approval · 2017-05-23FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) submitted by Orexo US, Inc.…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for buprenorphine by Sun Pharmaceutical Industries, Inc., through an ANDA supplement to modify or ad…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for buprenorphine from Rhodes Pharmaceuticals L.P., indicating regulatory action on an existing prod…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product for the t…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a generic Buprenorphine and Naloxone product from PAI Holdings under ANDA 204431.
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical's supplemental application for buprenorphine and naloxone, confirming continued approval/availability of thi…
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FDA approval · 2017-05-23FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for buprenorphine (generic), marking regulatory approval for the gene…
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FDA approval · 2017-03-27FDA Approved: BUPRENORPHINE — Original Application (Rhodes Pharmaceuticals L.P.)
FDA approves Rhodes Pharmaceuticals L.P.'s original ANDA application for a generic buprenorphine product.
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FDA approval · 2017-03-23FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental ANDA for buprenorphine and naloxone from Sun Pharmaceutical Industries, expanding access to a generic formulatio…
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FDA approval · 2017-03-10FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., approving the generic product's sup…
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FDA approval · 2017-01-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride from VistaPharm, LLC under the ANDA pathway.
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FDA approval · 2017-01-12FDA 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 · 2016-12-16FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for DISKETS (methadone hydrochloride) from Hikma Pharmaceuticals USA Inc., reflecting an approved su…
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FDA approval · 2016-12-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., finalizing the approval of a generi…
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FDA approval · 2016-12-16FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for Methadose (methadone hydrochloride) filed by SpecGx LLC.