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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 215334

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NDA 215334 describes PLERIXAFOR, which is a drug marketed by Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the PLERIXAFOR profile page.

The generic ingredient in PLERIXAFOR is plerixafor. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the plerixafor profile page.

Summary for 215334

Tradename:	PLERIXAFOR
Applicant:	Amneal
Ingredient:	plerixafor
Patents:	0

Pharmacology for NDA: 215334

Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

Suppliers and Packaging for NDA: 215334

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	215334	ANDA	Amneal Pharmaceuticals LLC	70121-1694	70121-1694-2	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1694-2) / 1.2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	24MG/1.2ML (20MG/ML)
Approval Date:	Jul 24, 2023	TE:	AP	RLD:	No

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