LYOPHILIZED PEGASPARGASE
Lyophilized Pegaspargase (750 U/mL) Export Only
Approved
Approval ID
95b28db2-479c-45d9-a1eb-3731d65da5c5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2020
Manufacturers
FDA
Servier Pharmaceuticals
DUNS: 116608503
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pegaspargase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72694-313
Product Classification
G
Generic Name
Pegaspargase
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 3, 2020
FDA Product Classification
INGREDIENTS (7)
PEGASPARGASEActive
Quantity: 750 [iU] in 1 mL
Code: 7D96IR0PPM
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT