Details for New Drug Application (NDA): 022101
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NDA 022101 describes NEXIUM, which is a drug marketed by Astrazeneca and Astrazeneca Lp and is included in six NDAs. It is available from one supplier. Additional details are available on the NEXIUM profile page.
The generic ingredient in NEXIUM is esomeprazole sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
The generic ingredient in NEXIUM is esomeprazole sodium. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 022101
| Tradename: | NEXIUM |
| Applicant: | Astrazeneca |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 022101
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 022101
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022101 | NDA | AstraZeneca Pharmaceuticals LP | 0186-4010 | 0186-4010-01 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 10MG BASE/PACKET | ||||
| Approval Date: | Feb 27, 2008 | TE: | AB | RLD: | Yes | ||||
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