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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Fish and Richardson

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202342

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NDA 202342 describes ESOMEPRAZOLE STRONTIUM, which is a drug marketed by R2 Pharma Llc and is included in one NDA. It is available from four suppliers. Additional details are available on the ESOMEPRAZOLE STRONTIUM profile page.

The generic ingredient in ESOMEPRAZOLE STRONTIUM is esomeprazole strontium. There are seventy drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the esomeprazole strontium profile page.
Summary for 202342
Applicant:R2 Pharma Llc
Ingredient:esomeprazole strontium
Formulation / Manufacturing:see details
Pharmacology for NDA: 202342
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 ParaPRO LLC 52246-200 N 52246-200-30
ESOMEPRAZOLE STRONTIUM esomeprazole strontium CAPSULE, DELAYED RELEASE;ORAL 202342 NDA ParaPRO LLC 52246-400 N 52246-400-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED RELEASE;ORALStrength24.65MG
Approval Date:Aug 6, 2013TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength49.3MG
Approval Date:Aug 6, 2013TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chinese Patent Office
Farmers Insurance
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