FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
761354BLABIOGEN MA001TOFIDENCEINJECTABLE;INJECTION80MG/4MLTOCILIZUMAB-BAVI2023-09-29PrescriptionNo
002TOFIDENCEINJECTABLE;INJECTION200MG/10MLTOCILIZUMAB-BAVI2023-09-29PrescriptionNo
003TOFIDENCEINJECTABLE;INJECTION400MG/20MLTOCILIZUMAB-BAVI2023-09-29PrescriptionNo
217369NDABIOGEN INC001ZURZUVAECAPSULE;ORAL20MGZURANOLONE2023-08-04PrescriptionNo
002ZURZUVAECAPSULE;ORAL25MGZURANOLONE2023-08-04PrescriptionNo
003ZURZUVAECAPSULE;ORAL30MGZURANOLONE2023-08-04PrescriptionYes
215887NDABIOGEN MA001QALSODYSOLUTION;INTRATHECAL100MG/15ML (6.7MG/ML)TOFERSEN2023-04-25PrescriptionYes
216718NDABIOGEN US001SKYCLARYSCAPSULE;ORAL50MGOMAVELOXOLONE2023-02-28PrescriptionYes
761178BLABIOGEN INC001ADUHELMINJECTABLE;INJECTION170MG/1.7ML (100MG/ML)ADUCANUMAB-AVWA2021-06-07PrescriptionNo
002ADUHELMINJECTABLE;INJECTION300MG/3ML (100MG/ML)ADUCANUMAB-AVWA2021-06-07PrescriptionNo
211855NDABIOGEN INC001VUMERITYCAPSULE, DELAYED RELEASE;ORAL231MGDIROXIMEL FUMARATE2019-10-29PrescriptionYes
209531NDABIOGEN IDEC001SPINRAZASOLUTION;INTRATHECALEQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)NUSINERSEN SODIUM2016-12-23PrescriptionYes
761029BLABIOGEN001ZINBRYTAINJECTABLE;INJECTION150MG/MLDACLIZUMAB2016-05-27PrescriptionNo
125499BLABIOGEN IDEC INC001PLEGRIDYINJECTABLE;INJECTION125MICROGRAMS/0.5MLPEGINTERFERON BETA-1A2014-08-15PrescriptionNo
204063NDABIOGEN INC001TECFIDERACAPSULE, DELAYED RELEASE;ORAL120MGDIMETHYL FUMARATE2013-03-27PrescriptionNo
002TECFIDERACAPSULE, DELAYED RELEASE;ORAL240MGDIMETHYL FUMARATE2013-03-27PrescriptionYes
125104BLABIOGEN IDEC001TYSABRIVIAL; SINGLE-USE300MGNATALIZUMAB2004-11-23PrescriptionNo
103628BLABIOGEN001AVONEXVIAL30UG/MLINTERFERON BETA-1A1996-05-17PrescriptionNo