Details for New Drug Application (NDA): 021229
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NDA 021229 describes PRILOSEC OTC, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the PRILOSEC OTC profile page.
The generic ingredient in PRILOSEC OTC is omeprazole magnesium. There is one drug master file entry 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 OTC is omeprazole magnesium. There is one drug master file entry for this compound. Sixty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
Summary for 021229
| Tradename: | PRILOSEC OTC |
| Applicant: | Astrazeneca |
| Ingredient: | omeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 021229
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 021229
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229 | NDA | The Procter & Gamble Manufacturing Company | 37000-455 | 37000-455-01 | 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01) |
| PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229 | NDA | The Procter & Gamble Manufacturing Company | 37000-455 | 37000-455-02 | 1 BLISTER PACK in 1 CARTON (37000-455-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jun 20, 2003 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021229
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