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Details for New Drug Application (NDA): 021877

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NDA 021877 describes ARRANON, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ARRANON profile page.

The generic ingredient in ARRANON is nelarabine. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

Summary for NDA: 021877

Tradename:
ARRANON
Applicant:
Novartis Pharms Corp
Ingredient:
nelarabine
Patents:1

Pharmacology for NDA: 021877

Suppliers and Packaging for NDA: 021877

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARRANON
nelarabine
INJECTABLE;IV (INFUSION) 021877 NDA GlaxoSmithKline LLC 0007-4401 0007-4401-06 6 VIAL, GLASS in 1 CARTON (0007-4401-06) > 50 mL in 1 VIAL, GLASS (0007-4401-01)
ARRANON
nelarabine
INJECTABLE;IV (INFUSION) 021877 NDA Novartis Pharmaceuticals Corporation 0078-0683 0078-0683-06 6 VIAL in 1 CARTON (0078-0683-06) > 50 mL in 1 VIAL (0078-0683-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength250MG/50ML (5MG/ML)
Approval Date:Oct 28, 2005TE:RLD:Yes
Patent:5,424,295Patent Expiration:Jun 13, 2017Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 021877

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 20055,492,897► subscribe
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 20055,821,236► subscribe
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 20055,747,472► subscribe
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