Details for New Drug Application (NDA): 021689
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The generic ingredient in NEXIUM IV is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 021689
Tradename: | NEXIUM IV |
Applicant: | Astrazeneca |
Ingredient: | esomeprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 021689
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 021689
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689 | NDA | AstraZeneca Pharmaceuticals LP | 0186-6040 | 0186-6040-01 | 10 VIAL in 1 CARTON (0186-6040-01) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Mar 31, 2005 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
Approval Date: | Mar 31, 2005 | TE: | RLD: | Yes |
Expired US Patents for NDA 021689
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-002 | Mar 31, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-001 | Mar 31, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-002 | Mar 31, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-001 | Mar 31, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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