Details for New Drug Application (NDA): 216149
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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 216149
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Guardian Drug |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216149
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 216149
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216149 | ANDA | Guardian Drug Company | 53041-666 | 53041-666-07 | 1 BOTTLE in 1 CARTON (53041-666-07) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 15, 2023 | TE: | RLD: | No |
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