Details for New Drug Application (NDA): 213201
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The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 213201
Tradename: | OMEPRAZOLE MAGNESIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | omeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 213201
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213201
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE MAGNESIUM | omeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 213201 | ANDA | Aurohealth LLC | 58602-837 | 58602-837-05 | 1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Apr 28, 2023 | TE: | RLD: | No |
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