Opioid Use Disorder
📧 Sign up to get email alerts when something new happens for Opioid Use Disorder.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2015-06-10FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd)
FDA approved Advagen Pharma Ltd's original application for buprenorphine hydrochloride, authorizing a generic product of buprenorphine for a…
-
FDA approval · 2015-06-04FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for methadone hydrochloride (generic methadone HCl) from Ascend Laboratories, LLC. The approval cove…
-
FDA approval · 2015-06-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
The FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) from Orexo US, Inc., typica…
-
FDA approval · 2015-06-01FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC under an ANDA, indicating an updated/added approval for …
-
FDA approval · 2015-05-14FDA Approved: NALTREXONE HYDROCHLORIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for naltrexone hydrochloride by Accord Healthcare, Inc., authorizing a new generic product.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2015-02-12FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals' supplemental application for buprenorphine HCl and naloxone HCl.
-
FDA approval · 2015-02-12FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine hydrochloride and naloxone hydrochloride) by Orexo US, Inc.
-
FDA approval · 2015-02-12FDA 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 from Hikm…
-
FDA approval · 2015-02-12FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a generic buprenorphine hydrochloride product (ANDA 090622) from PAI Holdings/PAI Pharma.
-
FDA approval · 2015-02-05FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' supplemental ANDA for a generic buprenorphine HCl and naloxone HCl product for the treatment of opioid …
-
FDA approval · 2015-02-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved Actavis Pharma, Inc.'s supplemental application for Buprenorphine and Naloxone.
-
FDA approval · 2015-02-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Hikma's buprenorphine hydrochloride and naloxone hydrochloride dihydrate product for opioid use …
-
FDA approval · 2014-12-13FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride manufactured by SpecGx LLC. This approval confirms the continued sta…
-
FDA approval · 2014-12-13FDA Approved: METHADOSE DISPERSIBLE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for METHADOSE DISPERSIBLE, a dispersible methadone hydrochloride product filed by SpecGx LLC.
-
FDA approval · 2014-12-11FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc.
-
FDA approval · 2014-11-05FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC, granting supplemental approval for a generic pr…
-
FDA approval · 2014-09-22FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadose (methadone hydrochloride) submitted by SpecGx LLC.
-
FDA approval · 2014-08-29FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) submitted by Alkermes, potentially expanding its labeling or indicatio…
-
FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application from VistaPharm, LLC for methadone hydrochloride, updating an existing ANDA product.
-
FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. under an ANDA.
-
FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., authorizing the generic product…
-
FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Methadone Hydrochloride from Ascend Laboratories, LLC, confirming approval of a generic methadon…
-
FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride by VistaPharm, LLC under ANDA090707, enabling a generic methadone hy…
-
FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC for this generic product.
-
FDA approval · 2014-08-12FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE, the buprenorphine/naloxone product from Indivior, indicating regulatory approval f…