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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 216346


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NDA 216346 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 216346
Tradename:NELARABINE
Applicant:Amneal
Ingredient:nelarabine
Patents:0
Pharmacology for NDA: 216346
Suppliers and Packaging for NDA: 216346
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NELARABINE nelarabine INJECTABLE;INTRAVENOUS 216346 ANDA Amneal Pharmaceuticals LLC 70121-1743 70121-1743-4 6 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE (70121-1743-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/50ML (5MG/ML)
Approval Date:Apr 4, 2023TE:APRLD:No

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