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PLERIXAFOR

PLERIXAFOR injection, for subcutaneous use

Approved
Approval ID

43df348a-d7f2-4f14-8131-c916679a98eb

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 28, 2023

Manufacturers
FDA

Zydus Lifesciences Limited

DUNS: 918596198

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

plerixafor

PRODUCT DETAILS

NDC Product Code70771-1776
Application NumberANDA208980
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 28, 2023
Generic Nameplerixafor

INGREDIENTS (5)

HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PLERIXAFORActive
Quantity: 24 mg in 1.2 mL
Code: S915P5499N
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 5.9 mg in 1.2 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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PLERIXAFOR - FDA Approval | MedPath