Details for New Drug Application (NDA): 214920
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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 214920
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Prinston Inc |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 214920
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 214920
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 214920 | ANDA | Solco Healthcare US LLC | 43547-001 | 43547-001-03 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-03) |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 214920 | ANDA | Solco Healthcare US LLC | 43547-001 | 43547-001-09 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-001-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 28, 2023 | 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: | Mar 28, 2023 | TE: | AB | RLD: | No |
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