Palynziq
These highlights do not include all the information needed to use PALYNZIQ safely and effectively. See full prescribing information for PALYNZIQ. PALYNZIQ (pegvaliase-pqpz) injection, for subcutaneous use Initial U.S. Approval: 2018
Approved
Approval ID
6dba844a-db02-44f8-8593-ce497ed9406c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2022
Manufacturers
FDA
BioMarin Pharmaceutical Inc.
DUNS: 079722386
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegvaliase-pqpz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68135-756
Application NumberBLA761079
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegvaliase-pqpz
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 20, 2020
FDA Product Classification
INGREDIENTS (1)
PEGVALIASEActive
Quantity: 10 mg in 0.5 mL
Code: N6UAH27EUV
Classification: ACTIB
pegvaliase-pqpz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68135-673
Application NumberBLA761079
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegvaliase-pqpz
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 20, 2020
FDA Product Classification
INGREDIENTS (1)
PEGVALIASEActive
Quantity: 20 mg in 1 mL
Code: N6UAH27EUV
Classification: ACTIB
pegvaliase-pqpz
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68135-058
Application NumberBLA761079
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegvaliase-pqpz
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 20, 2020
FDA Product Classification
INGREDIENTS (1)
PEGVALIASEActive
Quantity: 2.5 mg in 0.5 mL
Code: N6UAH27EUV
Classification: ACTIB