Details for New Drug Application (NDA): 213859
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The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 213859
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Guangzhou Novaken |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 213859
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213859
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 213859 | ANDA | Somerset Therapeutics, LLC | 70069-814 | 70069-814-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-814-10) |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 213859 | ANDA | Somerset Therapeutics, LLC | 70069-814 | 70069-814-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70069-814-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Nov 18, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Nov 18, 2020 | TE: | AB | RLD: | No |
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