Details for New Drug Application (NDA): 021957
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NDA 021957 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 seventy-four drug master file entries for this compound. Five 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 seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 021957
| Tradename: | NEXIUM |
| Applicant: | Astrazeneca |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 021957
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 021957
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957 | NDA | AstraZeneca Pharmaceuticals LP | 0186-4020 | 0186-4020-01 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4020-01) |
| NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957 | NDA | AstraZeneca Pharmaceuticals LP | 0186-4025 | 0186-4025-01 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4025-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE/PACKET | ||||
| Approval Date: | Oct 20, 2006 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE/PACKET | ||||
| Approval Date: | Oct 20, 2006 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 2.5MG BASE/PACKET | ||||
| Approval Date: | Dec 15, 2011 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021957
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-001 | Oct 20, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-001 | Oct 20, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | ⤷ Subscribe | ⤷ Subscribe |
| Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-001 | Oct 20, 2006 | ⤷ Subscribe | ⤷ Subscribe |
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