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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021986

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SPRYCEL (DASATINIB)
20MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: SPRYCEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021986
Product Number: 001
Approval Date: Jun 28, 2006
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
SPRYCEL (DASATINIB)
50MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: SPRYCEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021986
Product Number: 002
Approval Date: Jun 28, 2006
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
SPRYCEL (DASATINIB)
70MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: SPRYCEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 70MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021986
Product Number: 003
Approval Date: Jun 28, 2006
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
SPRYCEL (DASATINIB)
80MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: SPRYCEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021986
Product Number: 005
Approval Date: Oct 28, 2010
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
SPRYCEL (DASATINIB)
100MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: SPRYCEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021986
Product Number: 004
Approval Date: May 30, 2008
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
SPRYCEL (DASATINIB)
140MG
Marketing Status: Prescription
Active Ingredient: DASATINIB
Proprietary Name: SPRYCEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 140MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021986
Product Number: 006
Approval Date: Oct 28, 2010
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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