Details for New Drug Application (NDA): 205379
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The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 205379
Tradename: | ESOMEPRAZOLE SODIUM |
Applicant: | Accord Hlthcare |
Ingredient: | esomeprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205379
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 205379
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 205379 | ANDA | Accord Healthcare Inc. | 16729-252 | 16729-252-66 | 1 VIAL in 1 CARTON (16729-252-66) / 5 mL in 1 VIAL |
ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 205379 | ANDA | Accord Healthcare Inc. | 16729-252 | 16729-252-69 | 10 VIAL in 1 CARTON (16729-252-69) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
Approval Date: | Sep 25, 2015 | TE: | AP | RLD: | No |
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