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Last Updated: November 27, 2024

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 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
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:RXDosage:SOLUTION;SUBCUTANEOUSStrength24MG/1.2ML (20MG/ML)
Approval Date:Jul 24, 2023TE:APRLD:No

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