Details for New Drug Application (NDA): 021153
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NDA 021153 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 021153
| Tradename: | NEXIUM |
| Applicant: | Astrazeneca |
| Ingredient: | esomeprazole magnesium |
| Patents: | 0 |
Pharmacology for NDA: 021153
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 021153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153 | NDA | AstraZeneca Pharmaceuticals LP | 0186-5020 | 0186-5020-31 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31) |
| NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153 | NDA | AstraZeneca Pharmaceuticals LP | 0186-5020 | 0186-5020-54 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Feb 20, 2001 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Feb 20, 2001 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 021153
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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