Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-03-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
FDA approved a supplemental application for Methadone Hydrochloride from Aurolife Pharma, authorizing a generic formulation of the opioid me…
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FDA approval · 2024-01-03FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadone hydrochloride from SpecGx LLC, approving changes to an existing generic product under …
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FDA approval · 2024-01-03FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride (SpecGx LLC), finalizing an updated regulatory authorization under an AN…
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FDA approval · 2023-12-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC.
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FDA approval · 2023-12-15FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for DISKETS (methadone hydrochloride) from Hikma Pharmaceuticals USA Inc., indicating an approve…
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FDA approval · 2023-12-15FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadose (methadone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2023-12-15FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for Suboxone (buprenorphine hydrochloride/naloxone hydrochloride) from Indivior Inc., authorizin…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine hydrochloride (ANDA 090622) from PAI Holdings/PAI Pharma, confirming the approval …
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FDA approval · 2023-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by Mylan Institutional LLC, updating regulatory status for…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride …
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc. The action indicates an additional approval under an…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for a buprenorphine and naloxone product by Lannett Company, Inc., resulting in approval of this gen…
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FDA approval · 2023-12-15FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
FDA approves a supplemental application for SUBLOCADE (buprenorphine) by Indivior Inc., expanding the approved use of the extended-release i…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for the generic fixed-dose combination of buprenorphine hydrochloride and naloxone hydrochloride dih…
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FDA approval · 2023-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
FDA approved a supplemental application for methadone hydrochloride from Camber Pharmaceuticals, Inc. This action grants continued approval …
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for a generic buprenorphine and naloxone product from Rhodes Pharmaceuticals L.P., indicating regula…
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FDA approval · 2023-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride manufactured by Hikma Pharmaceuticals USA Inc., updating the approved pr…
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FDA approval · 2023-12-15FDA Approved: BRIXADI — Supplemental Application (Braeburn Inc.)
The FDA approved Braeburn Inc.'s supplemental application for BRIXADI (buprenorphine), indicating an update to the product's labeling under …
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FDA approval · 2023-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride by VistaPharm, LLC, indicating changes to the existing approval for the …
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application for a generic buprenorphine HCl and naloxone HCl product for opioid use disorder. This is an …
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Buprenorphine and Naloxone from Actavis Pharma, Inc.
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FDA approval · 2023-12-15FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride (methadone) by VistaPharm, LLC. This represents an additional approval f…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for buprenorphine by Sun Pharmaceutical Industries, Inc. This action approves changes to the bupreno…
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
The FDA approved a supplemental application for buprenorphine and naloxone (generic product) from PAI Holdings/PAI Pharma.
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FDA approval · 2023-12-15FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
FDA approved a supplemental application for Accord Healthcare's generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate pro…