FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
214938NDABIOMARIN PHARM001VOXZOGOPOWDER;SUBCUTANEOUS0.4MG/VIALVOSORITIDE2021-11-19PrescriptionYes
002VOXZOGOPOWDER;SUBCUTANEOUS0.56MG/VIALVOSORITIDE2021-11-19PrescriptionYes
003VOXZOGOPOWDER;SUBCUTANEOUS1.2MG/VIALVOSORITIDE2021-11-19PrescriptionYes
761079BLABIOMARIN PHARM001PALYNZIQINJECTABLE;INJECTION2.5MG/O.5MLPEGVALIASE-PQPZ2018-05-24PrescriptionNo
002PALYNZIQINJECTABLE;INJECTION10MG/0.5MLPEGVALIASE-PQPZ2018-05-24PrescriptionNo
003PALYNZIQINJECTABLE;INJECTION20MG/MLPEGVALIASE-PQPZ2018-05-24PrescriptionNo
761052BLABIOMARIN PHARM001BRINEURAINJECTABLE;INJECTION30MG/MLCERLIPONASE ALFA2017-04-27PrescriptionNo
125460BLABIOMARIN PHARM001VIMIZIMINJECTABLE;INJECTION5MG/5MLELOSULFASE ALFA2014-02-14PrescriptionNo
205065NDABIOMARIN PHARM001KUVANPOWDER;ORAL100MG/PACKETSAPROPTERIN DIHYDROCHLORIDE2013-12-19PrescriptionYes
002KUVANPOWDER;ORAL500MG/PACKETSAPROPTERIN DIHYDROCHLORIDE2013-12-19PrescriptionNo
022181NDABIOMARIN PHARM001KUVANTABLET;ORAL100MGSAPROPTERIN DIHYDROCHLORIDE2007-12-13PrescriptionYes
125117BLABIOMARIN001NAGLAZYMEINJECTABLE; INJECTION5MG/5MLGALSULFASE2005-05-31PrescriptionNo
125058BLABIOMARIN001ALDURAZYMEVIAL2.9MG/MLLARONIDASE2003-04-30PrescriptionNo