Details for New Drug Application (NDA): 202342
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NDA 202342 describes ESOMEPRAZOLE STRONTIUM, which is a drug marketed by Belcher and is included in one NDA. It is available from one supplier. Additional details are available on the ESOMEPRAZOLE STRONTIUM profile page.
The generic ingredient in ESOMEPRAZOLE STRONTIUM is esomeprazole strontium. There are seventy-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the esomeprazole strontium profile page.
The generic ingredient in ESOMEPRAZOLE STRONTIUM is esomeprazole strontium. There are seventy-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the esomeprazole strontium profile page.
Summary for 202342
| Tradename: | ESOMEPRAZOLE STRONTIUM |
| Applicant: | Belcher |
| Ingredient: | esomeprazole strontium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202342
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 202342
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342 | NDA | R2 Pharma, LLC | 70849-200 | 70849-200-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30) |
| ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | CAPSULE, DELAYED RELEASE;ORAL | 202342 | NDA | R2 Pharma, LLC | 70849-400 | 70849-400-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-400-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 24.65MG | ||||
| Approval Date: | Aug 6, 2013 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 49.3MG | ||||
| Approval Date: | Aug 6, 2013 | TE: | RLD: | Yes | |||||
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