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Covington
Daiichi Sankyo
Colorcon
Deloitte
Merck
Dow
US Army
Moodys
Healthtrust

Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021986

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NDA 021986 describes SPRYCEL, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SPRYCEL profile page.

The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
Summary for 021986
Tradename:SPRYCEL
Applicant:Bristol Myers Squibb
Ingredient:dasatinib
Patents:5
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021986
Medical Subject Heading (MeSH) Categories for 021986
Suppliers and Packaging for NDA: 021986
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPRYCEL dasatinib TABLET;ORAL 021986 NDA E.R. Squibb & Sons, L.L.C. 0003-0524 N 0003-0524-11
SPRYCEL dasatinib TABLET;ORAL 021986 NDA E.R. Squibb & Sons, L.L.C. 0003-0527 N 0003-0527-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 28, 2006TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 9, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Nov 9, 2024
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE
Patent:➤ Try a Free TrialPatent Expiration:Jun 28, 2020Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER

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Johnson and Johnson
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QuintilesIMS
Medtronic
Healthtrust
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