Details for New Drug Application (NDA): 204657
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NDA 204657 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Accord Hlthcare, Deva Holding As, Eugia Pharma, Gland Pharma Ltd, Mylan, Slate Run Pharma, and Sun Pharm, and is included in seven NDAs. It is available from four suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.
The generic ingredient in ESOMEPRAZOLE SODIUM 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.
The generic ingredient in ESOMEPRAZOLE SODIUM 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 204657
| Tradename: | ESOMEPRAZOLE SODIUM |
| Applicant: | Eugia Pharma |
| Ingredient: | esomeprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 204657
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 204657
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 204657 | ANDA | Eugia US LLC | 55150-185 | 55150-185-05 | 10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 20MG BASE/VIAL | ||||
| Approval Date: | Aug 10, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
| Approval Date: | Aug 10, 2016 | TE: | AP | RLD: | No | ||||
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