Details for New Drug Application (NDA): 216349
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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 216349
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Graviti Pharms |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 216349
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 216349
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216349 | ANDA | Rising Pharma Holdings, Inc. | 16571-880 | 16571-880-41 | 1 BOTTLE in 1 CARTON (16571-880-41) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 216349 | ANDA | Rising Pharma Holdings, Inc. | 16571-880 | 16571-880-42 | 3 BOTTLE in 1 CARTON (16571-880-42) / 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: | Jun 24, 2022 | TE: | RLD: | No |
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