Details for New Drug Application (NDA): 021689
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The generic ingredient in NEXIUM IV is esomeprazole sodium. There is one drug master file entry for this compound. Three 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 |
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| Strength | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Strength | EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| 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 | 021689-001 | Mar 31, 2005 | 6,143,771 | ⤷ Start Trial |
| Astrazeneca | NEXIUM IV | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 021689-002 | Mar 31, 2005 | 6,143,771 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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