FDA.reportPublic FDA data

Application 761079

Type
BLA
Sponsor
BIOMARIN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PALYNZIQPEGVALIASE-PQPZINJECTABLE;INJECTION2.5MG/O.5MLNoNo
002PALYNZIQPEGVALIASE-PQPZINJECTABLE;INJECTION10MG/0.5MLNoNo
003PALYNZIQPEGVALIASE-PQPZINJECTABLE;INJECTION20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68135-058Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-058Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-058Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-058Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-058Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-673Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-673Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-673Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-673Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-673Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-756Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-756Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-756Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-756Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent
68135-756Palynziqpegvaliase-pqpzBioMarin Pharmaceutical Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85213SUPPL 2026-03-16
85280SUPPL 2026-03-06
84259SUPPL 2025-11-21
84255SUPPL 2025-11-21
84254SUPPL 2025-11-21
76757SUPPL 2023-12-11
76289ORIG 2023-11-03
65309SUPPL2020-11-25
65297SUPPL2020-11-23
64876SUPPL2020-10-07
64857SUPPL2020-10-07
64856SUPPL2020-10-07
64855SUPPL2020-10-07
54723ORIG2018-06-28
54339ORIG2018-05-25
54338ORIG2018-05-24
54337ORIG2018-05-24