Details for New Drug Application (NDA): 022056
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The generic ingredient in PRILOSEC is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 022056
Tradename: | PRILOSEC |
Applicant: | Covis |
Ingredient: | omeprazole magnesium |
Patents: | 0 |
Pharmacology for NDA: 022056
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 022056
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056 | NDA | Covis Pharma US, Inc | 70515-610 | 70515-610-01 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-610-01) |
PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056 | NDA | Covis Pharma US, Inc | 70515-625 | 70515-625-01 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (70515-625-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 2.5MG BASE/PACKET | ||||
Approval Date: | Mar 20, 2008 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 10MG BASE/PACKET | ||||
Approval Date: | Mar 20, 2008 | TE: | RLD: | Yes |
Expired US Patents for NDA 022056
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-002 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-002 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-002 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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