Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. (ANDA 087393), granting approval of …
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
The FDA approved a supplemental application for methadone hydrochloride from Aurolife Pharma, LLC, enabling the generic product to be market…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride (generic methadone) submitted by VistaPharm, LLC under ANDA204166.
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride (generic) submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2021-05-06FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) from Alkermes, Inc.
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FDA approval · 2021-04-28FDA Approved: BUPRENORPHINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for buprenorphine from Teva Pharmaceuticals USA, Inc. under ANDA204937.
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FDA approval · 2021-03-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental ANDA for a generic buprenorphine and naloxone product, manufactured by PAI Holdings, LLC dba Pharmaceutical …
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FDA approval · 2021-03-04FDA Approved: VIVITROL — Supplemental Application (Alkermes, Inc.)
The FDA approved a supplemental application for VIVITROL (naltrexone) by Alkermes, Inc.
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FDA approval · 2021-03-04FDA 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.
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Hikma Pharmaceuticals USA Inc. for buprenorphine hydrochloride and naloxone hydrochloride di…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride filed by Advagen Pharma Ltd under the ANDA, authorizing changes to t…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's supplemental application for a buprenorphine and naloxone product under an ANDA, making a generic vers…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application from Lannett Company for buprenorphine and naloxone, adding a supplemental approval for a generic pr…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for buprenorphine submitted by Rhodes Pharmaceuticals L.P.
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride from PAI Holdings/PAI Pharma, enabling the generic product to be mar…
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FDA approval · 2021-03-04FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)
FDA approved a supplemental application for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc. The approval covers changes to labeling and…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine by Actavis Pharma, Inc.
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FDA approval · 2021-03-04FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
FDA approved a supplemental application for SUBLOCADE (buprenorphine) submitted by Indivior Inc.
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from SpecGx L…
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FDA approval · 2021-03-04FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
FDA approved a supplemental application from Accord Healthcare, Inc. for a generic buprenorphine hydrochloride and naloxone hydrochloride di…
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FDA approval · 2021-02-19FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Lannett Company's buprenorphine and naloxone product, affirming its approval for use in treating…
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FDA approval · 2021-02-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
FDA approved a supplemental application for Camber Pharmaceuticals' methadone hydrochloride, enabling an additional generic product supply u…
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FDA approval · 2021-02-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for methadone hydrochloride manufactured by Aurolife Pharma, LLC. This action updates the product's …
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FDA approval · 2021-02-18FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC.
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FDA approval · 2021-02-16FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for buprenorphine from Sun Pharmaceutical Industries under ANDA201760, related to a supplemental app…