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FDA Approval

Plerixafor

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Eugia US LLC
DUNS: 968961354
Effective Date
August 2, 2023
Labeling Type
Human Prescription Drug Label
Plerixafor(24 mg in 1.2 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

EUGIA Pharma Specialities Limited

Eugia US LLC

872201704

Products1

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

Plerixafor

Product Details

NDC Product Code
55150-356
Application Number
ANDA213672
Marketing Category
ANDA (C73584)
Route of Administration
SUBCUTANEOUS
Effective Date
August 2, 2023
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Code: S915P5499NClass: ACTIBQuantity: 24 mg in 1.2 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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