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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205197

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NDA 205197 describes PLERIXAFOR, which is a drug marketed by Amneal, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in nine 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 205197

Tradename:	PLERIXAFOR
Applicant:	Teva Pharms Usa Inc
Ingredient:	plerixafor
Patents:	0

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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