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Generated: November 13, 2018

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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 one supplier. 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. One supplier is 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
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 0003-0524-11 1 BOTTLE in 1 CARTON (0003-0524-11) > 60 TABLET in 1 BOTTLE
SPRYCEL dasatinib TABLET;ORAL 021986 NDA E.R. Squibb & Sons, L.L.C. 0003-0527 0003-0527-11 1 BOTTLE in 1 CARTON (0003-0527-11) > 60 TABLET in 1 BOTTLE

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:Dec 28, 2020Product Flag?Substance Flag?Delist Request?Y

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