You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 5, 2024

Details for New Drug Application (NDA): 205197

✉ Email this page to a colleague

« Back to Dashboard

NDA 205197 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 205197

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

Pharmacology for NDA: 205197

Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

Suppliers and Packaging for NDA: 205197

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	205197	ANDA	Teva Pharmaceuticals, Inc.	0480-4320	0480-4320-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4320-01) / 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.