Product Details for NDA 021689
NEXIUM IV (ESOMEPRAZOLE SODIUM)
EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESOMEPRAZOLE SODIUM
Proprietary Name: NEXIUM IV
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021689
Product Number: 001
Approval Date: Mar 31, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
NEXIUM IV (ESOMEPRAZOLE SODIUM)
Proprietary Name: NEXIUM IV
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021689
Product Number: 001
Approval Date: Mar 31, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ESOMEPRAZOLE SODIUM
Proprietary Name: NEXIUM IV
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021689
Product Number: 002
Approval Date: Mar 31, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: NEXIUM IV
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021689
Product Number: 002
Approval Date: Mar 31, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information