Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2018-02-01FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride, a generic product from Hikma Pharmaceuticals USA Inc., expanding its av…
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FDA approval · 2018-02-01FDA 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 · 2018-02-01FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approved a supplemental application for SUBOXONE (buprenorphine and naloxone) submitted by Indivior Inc.
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FDA approval · 2018-02-01FDA 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 for a generic product.
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal's supplemental application for buprenorphine HCl and naloxone HCl (buprenorphine and naloxone) under ANDA203136. The…
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FDA approval · 2018-02-01FDA 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 · 2018-02-01FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc. under an approved ANDA, reflecting an added or updat…
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for a buprenorphine and naloxone product, validating its use as …
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application from Hikma Pharmaceuticals USA Inc. to market a generic buprenorphine hydrochloride and naloxone…
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental ANDA for a generic buprenorphine and naloxone product manufactured by PAI Holdings, expanding access to this opi…
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for buprenorphine submitted by Hikma Pharmaceuticals USA Inc. (ANDA).
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for a generic buprenorphine and naloxone product manufactured by Lannett Company, expanding acce…
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FDA approval · 2018-02-01FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (Advagen Pharma Ltd)
FDA approved a supplemental application for buprenorphine hydrochloride by Advagen Pharma Ltd, granting approval for a generic product.
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FDA approval · 2018-01-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc. under ANDA 087997.
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FDA approval · 2018-01-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approves a supplemental application for Methadone Hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., supporting continued appr…
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FDA approval · 2018-01-31FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride by VistaPharm, LLC under ANDA090707, authorizing a revised/expanded labe…
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FDA approval · 2018-01-31FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal Pharmaceuticals' supplemental application for buprenorphine HCl and naloxone HCl (buprenorphine and naloxone), under…
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FDA approval · 2018-01-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental ANDA for BUPRENORPHINE AND NALOXONE from Actavis Pharma, Inc., approving its generic product for the treatment o…
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FDA approval · 2018-01-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a buprenorphine and naloxone product supplied by PAI Holdings/PAI Pharma, marking a supplemental…
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FDA approval · 2018-01-31FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for buprenorphine and naloxone. This action updates the product's label…
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FDA approval · 2018-01-31FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for buprenorphine (generic). The buprenorphine product is used to treat…
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FDA approval · 2017-12-13FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Original Application (SpecGx LLC)
FDA approved a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product for opioid dependence. This is the Original …
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FDA approval · 2017-11-30FDA Approved: SUBLOCADE — Original Application (Indivior Inc.)
FDA approved SUBLOCADE, a long-acting injectable buprenorphine, under the original application for the treatment of opioid use disorder.
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FDA approval · 2017-10-27FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Long Grove Pharmaceuticals, LLC)
FDA approves Long Grove Pharmaceuticals' methadone hydrochloride under an original application (ANDA 208306), establishing its generic produ…
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FDA approval · 2017-09-19FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
FDA approves a supplemental application for Suboxone (buprenorphine hydrochloride, naloxone hydrochloride) from Indivior Inc. The action ref…