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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021957

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NEXIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 2.5MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: NEXIUM
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 2.5MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021957
Product Number: 003
Approval Date: Dec 15, 2011
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
NEXIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 5MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: NEXIUM
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 5MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021957
Product Number: 004
Approval Date: Dec 15, 2011
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
NEXIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 20MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: NEXIUM
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 20MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021957
Product Number: 001
Approval Date: Oct 20, 2006
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
NEXIUM (ESOMEPRAZOLE MAGNESIUM)
EQ 40MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: ESOMEPRAZOLE MAGNESIUM
Proprietary Name: NEXIUM
Dosage Form; Route of Administration: FOR SUSPENSION, DELAYED RELEASE; ORAL
Strength: EQ 40MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021957
Product Number: 002
Approval Date: Oct 20, 2006
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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