FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
217470NDAINDIVIOR001OPVEESPRAY;NASALEQ 2.7MG BASE/SPRAYNALMEFENE HYDROCHLORIDE2023-05-22PrescriptionYes
210655NDAINDIVIOR001PERSERIS KITFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS90MGRISPERIDONE2018-07-27PrescriptionNo
002PERSERIS KITFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS120MGRISPERIDONE2018-07-27PrescriptionYes
209819NDAINDIVIOR001SUBLOCADESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS100MG/0.5ML (100MG/0.5ML)BUPRENORPHINE2017-11-30PrescriptionNo
002SUBLOCADESOLUTION, EXTENDED RELEASE;SUBCUTANEOUS300MG/1.5ML (200MG/ML)BUPRENORPHINE2017-11-30PrescriptionYes
022410NDAINDIVIOR001SUBOXONEFILM;BUCCAL, SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE2010-08-30PrescriptionNo
002SUBOXONEFILM;BUCCAL, SUBLINGUALEQ 8MG BASE;EQ 2MG BASEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE2010-08-30PrescriptionNo
003SUBOXONEFILM;BUCCAL, SUBLINGUALEQ 4MG BASE;EQ 1MG BASEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE2010-08-30PrescriptionNo
004SUBOXONEFILM;BUCCAL, SUBLINGUALEQ 12MG BASE;EQ 3MG BASEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE2010-08-30PrescriptionYes
020733NDAINDIVIOR001SUBOXONETABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE2002-10-08DiscontinuedNo
002SUBOXONETABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE2002-10-08DiscontinuedNo
020732NDAINDIVIOR002SUBUTEXTABLET;SUBLINGUALEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BUPRENORPHINE HYDROCHLORIDE2002-10-08DiscontinuedNo
003SUBUTEXTABLET;SUBLINGUALEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BUPRENORPHINE HYDROCHLORIDE2002-10-08DiscontinuedNo
018401NDAINDIVIOR001BUPRENEXINJECTABLE;INJECTIONEQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BUPRENORPHINE HYDROCHLORIDE1981-12-29DiscontinuedNo