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Last Updated: July 10, 2020

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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 Acrotech 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 202497
Tradename:MARQIBO KIT
Applicant:Acrotech
Ingredient:vincristine sulfate
Patents:3
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202497
Suppliers and Packaging for NDA: 202497
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MARQIBO KIT 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INTRAVENOUSStrength5MG/5ML (1MG/ML)
Approval Date:Aug 9, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 31, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS PROGRESSED FOLLOWING TWO OR MORE ANTI-LEUKEMIA THERAPIES
Patent:  Start TrialPatent Expiration:Sep 25, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 31, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS PROGRESSED FOLLOWING TWO OR MORE ANTI-LEUKEMIA THERAPIES

Expired US Patents for NDA 202497

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012   Start Trial   Start Trial
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012   Start Trial   Start Trial
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012   Start Trial   Start Trial
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012   Start Trial   Start Trial
Acrotech MARQIBO KIT vincristine sulfate INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497-001 Aug 9, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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