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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021986."



Active Ingredient: DASATINIB
Dosage Form;Route: TABLET;ORAL
Proprietary Name: SPRYCEL
Applicant: BRISTOL MYERS SQUIBB
Strength: 20MG
Application Number: N021986
Product Number: 001
Approval Date: Jun 28, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DASATINIB
Dosage Form;Route: TABLET;ORAL
Proprietary Name: SPRYCEL
Applicant: BRISTOL MYERS SQUIBB
Strength: 50MG
Application Number: N021986
Product Number: 002
Approval Date: Jun 28, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DASATINIB
Dosage Form;Route: TABLET;ORAL
Proprietary Name: SPRYCEL
Applicant: BRISTOL MYERS SQUIBB
Strength: 70MG
Application Number: N021986
Product Number: 003
Approval Date: Jun 28, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DASATINIB
Dosage Form;Route: TABLET;ORAL
Proprietary Name: SPRYCEL
Applicant: BRISTOL MYERS SQUIBB
Strength: 100MG
Application Number: N021986
Product Number: 004
Approval Date: May 30, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DASATINIB
Dosage Form;Route: TABLET;ORAL
Proprietary Name: SPRYCEL
Applicant: BRISTOL MYERS SQUIBB
Strength: 80MG
Application Number: N021986
Product Number: 005
Approval Date: Oct 28, 2010
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DASATINIB
Dosage Form;Route: TABLET;ORAL
Proprietary Name: SPRYCEL
Applicant: BRISTOL MYERS SQUIBB
Strength: 140MG
Application Number: N021986
Product Number: 006
Approval Date: Oct 28, 2010
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 2014
Patent and Generic Drug Product Data Last Updated July 28, 2014

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