Details for New Drug Application (NDA): 210559
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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 twelve suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 210559
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Indchemie Health |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 210559
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 210559
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 210559 | ANDA | A-S Medication Solutions | 50090-5777 | 50090-5777-1 | 90 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-5777-1) |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 210559 | ANDA | Ascend Laboratories, LLC | 67877-571 | 67877-571-05 | 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Feb 26, 2021 | 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: | Feb 26, 2021 | TE: | AB | RLD: | No |
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