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Details for New Drug Application (NDA): 202497

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NDA 202497 describes MARQIBO KIT, which is a drug marketed by Talon Therap and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MARQIBO KIT profile page.

The generic ingredient in MARQIBO KIT is vincristine sulfate. There are thirteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vincristine sulfate profile page.

Summary for NDA: 202497

Talon Therap
vincristine sulfate
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202497

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497 NDA Talon Therapeutics, Inc. 20536-322 20536-322-01 1 KIT in 1 CARTON (20536-322-01) * 1 mL in 1 VIAL, GLASS (20536-324-01) * 25 mL in 1 VIAL, GLASS (20536-325-01) * 5 mL in 1 VIAL, GLASS (20536-323-01)

Summary for product number 001

Approval Date:Aug 9, 2012TE:RLD:Yes
Patent:7,247,316Patent Expiration:Sep 25, 2020Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Aug 9, 2015
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Aug 9, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 202497

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Talon Therap
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,543,152► subscribe
Talon Therap
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,814,335► subscribe
Talon Therap
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 20125,741,516► subscribe
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