Details for New Drug Application (NDA): 207891
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The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 207891
Tradename: | OMEPRAZOLE |
Applicant: | Sun Pharm |
Ingredient: | omeprazole |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207891
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 207891
Suppliers and Packaging for NDA: 207891
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE | omeprazole | TABLET, DELAYED RELEASE;ORAL | 207891 | ANDA | THE KROGER COMPANY | 30142-992 | 30142-992-14 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (30142-992-14) |
OMEPRAZOLE | omeprazole | TABLET, DELAYED RELEASE;ORAL | 207891 | ANDA | THE KROGER COMPANY | 30142-992 | 30142-992-28 | 2 TABLET, DELAYED RELEASE in 1 CARTON (30142-992-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 12, 2018 | TE: | RLD: | No |
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