Details for New Drug Application (NDA): 019810
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NDA 019810 describes PRILOSEC, which is a drug marketed by Astrazeneca and Azurity 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 two drug master file entries for this compound. Sixty 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 two drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 019810
| Tradename: | PRILOSEC |
| Applicant: | Astrazeneca |
| Ingredient: | omeprazole |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 019810
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 14, 1989 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 15, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 5, 1995 | TE: | RLD: | Yes | |||||
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