Opioid Use Disorder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for a buprenorphine and naloxone product from Mylan Pharmaceuticals Inc., enabling continued mar…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for Buprenorphine and Naloxone from Dr. Reddy's Laboratories Inc., indicating an approved supplement…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Rhodes Pharmaceuticals L.P.)
The FDA approved a supplemental application for a buprenorphine/naloxone product from Rhodes Pharmaceuticals L.P., supporting continued mark…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for Mylan Pharmaceuticals' buprenorphine/naloxone product, confirming continued approval for tre…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (INGENUS PHARMACEUTICALS, LLC)
FDA approved a supplemental application for a generic buprenorphine/naloxone product from Ingenus Pharmaceuticals, LLC, enabling its continu…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Hikma Pharmaceuticals USA Inc. to market a buprenorphine generic product under ANDA 078633.
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc., indicating updated labeling for this gener…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Hikma's buprenorphine hydrochloride and naloxone hydrochloride dihydrate, expanding its appr…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Sun Pharmaceutical's buprenorphine/naloxone product. This approval signifies changes to the …
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE — Supplemental Application (Accord Healthcare, Inc)
The FDA approved a supplemental application for a generic buprenorphine hydrochloride and naloxone hydrochloride dihydrate product from Acco…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for buprenorphine and naloxone from PAI Holdings/PAI Pharma, indicating an additional regulatory app…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM — Supplemental Application (Alvogen Inc.)
FDA approved a supplemental application for the generic buprenorphine and naloxone sublingual film from Alvogen Inc., authorizing market aut…
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FDA approval · 2022-12-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for a generic buprenorphine and naloxone product manufactured by Dr. Reddy's Laboratories Inc for op…
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FDA approval · 2022-12-14FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by VistaPharm, LLC.
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FDA approval · 2022-12-13FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine and naloxone from Actavis Pharma, Inc.
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FDA approval · 2022-12-06FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for buprenorphine and naloxone from Dr. Reddy's Laboratories, enabling a generic product for the tre…
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FDA approval · 2022-12-06FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Dr.Reddys Laboratories Inc)
FDA approved a supplemental application for a buprenorphine and naloxone product from Dr. Reddy's Laboratories Inc. for the treatment of opi…
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FDA approval · 2022-11-16FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical's supplemental application for a generic buprenorphine and naloxone product. This approval expands the a…
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FDA approval · 2022-08-23FDA Approved: SUBLOCADE — Supplemental Application (Indivior Inc.)
The FDA approved a supplemental application for SUBLOCADE (buprenorphine extended-release) from Indivior Inc., updating the product's labeli…
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FDA approval · 2022-06-17FDA Approved: SUBOXONE — Supplemental Application (INDIVIOR INC.)
The FDA approved a supplemental application for SUBOXONE (buprenorphine hydrochloride/naloxone hydrochloride) submitted by Indivior Inc.
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE HCL AND NALOXONE HCL — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Amneal's buprenorphine HCl and naloxone HCl tablets, enabling a generic option for treating opio…
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for buprenorphine and naloxone by Actavis Pharma, Inc. This approval updates the product's labeling …
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for buprenorphine submitted by Actavis Pharma, Inc.
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FDA approval · 2022-06-17FDA 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 buprenorphine/naloxone product (buprenorphine hydrochloride and naloxone hydrochloride) from PAI …
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FDA approval · 2022-06-17FDA Approved: BUPRENORPHINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for buprenorphine submitted by Sun Pharmaceutical Industries, Inc.