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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216948


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NDA 216948 describes NELARABINE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Gland Pharma Ltd, Meitheal, MSN, Nexus, Shorla, Xgen Pharms, and Zydus Pharms, and is included in ten NDAs. It is available from twelve suppliers. Additional details are available on the NELARABINE profile page.

The generic ingredient in NELARABINE is nelarabine. There are two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.
Summary for 216948
Tradename:NELARABINE
Applicant:Msn
Ingredient:nelarabine
Patents:0
Pharmacology for NDA: 216948
Suppliers and Packaging for NDA: 216948
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216948 ANDA Novadoz Pharmaceuticals LLC 72205-154 72205-154-01 1 VIAL in 1 CARTON (72205-154-01) / 50 mL in 1 VIAL
NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216948 ANDA Novadoz Pharmaceuticals LLC 72205-154 72205-154-04 6 VIAL in 1 CARTON (72205-154-04) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/50ML (5MG/ML)
Approval Date:Sep 13, 2024TE:APRLD:No

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