Details for New Drug Application (NDA): 202342
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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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