Details for New Drug Application (NDA): 022056
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NDA 022056 describes PRILOSEC, which is a drug marketed by Astrazeneca and Covis and is included in three NDAs. It is available from one supplier. Additional details are available on the PRILOSEC profile page.
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.
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 | 022056-002 | Mar 20, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-002 | Mar 20, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-002 | Mar 20, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Subscribe | ⤷ Subscribe |
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Subscribe | ⤷ Subscribe |
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