Details for New Drug Application (NDA): 208333
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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 208333
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Alkem Labs Ltd |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 208333
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 208333
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 208333 | ANDA | Ascend Laboratories, LLC | 67877-478 | 67877-478-05 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-05) |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 208333 | ANDA | Ascend Laboratories, LLC | 67877-478 | 67877-478-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Oct 20, 2017 | 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: | Oct 20, 2017 | TE: | AB | RLD: | No |
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