Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 "021957."


Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Dosage Form;Route: FOR SUSPENSION, DELAYED RELEASE; ORAL
Proprietary Name: NEXIUM
Applicant: ASTRAZENECA
Strength: EQ 20MG BASE/PACKET
Application Number: N021957
Product Number: 001
Approval Date: Oct 20, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Dosage Form;Route: FOR SUSPENSION, DELAYED RELEASE; ORAL
Proprietary Name: NEXIUM
Applicant: ASTRAZENECA
Strength: EQ 40MG BASE/PACKET
Application Number: N021957
Product Number: 002
Approval Date: Oct 20, 2006
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Dosage Form;Route: FOR SUSPENSION, DELAYED RELEASE; ORAL
Proprietary Name: NEXIUM
Applicant: ASTRAZENECA
Strength: EQ 2.5MG BASE/PACKET
Application Number: N021957
Product Number: 003
Approval Date: Dec 15, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Dosage Form;Route: FOR SUSPENSION, DELAYED RELEASE; ORAL
Proprietary Name: NEXIUM
Applicant: ASTRAZENECA
Strength: EQ 5MG BASE/PACKET
Application Number: N021957
Product Number: 004
Approval Date: Dec 15, 2011
Reference Listed Drug No
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 April, 2013
    Patent and Generic Drug Product Data Last Updated: May 22, 2013
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