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Details for New Drug Application (NDA): 202342

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NDA 202342 describes ESOMEPRAZOLE STRONTIUM, which is a drug marketed by Hanmi Pharm Co Ltd 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 sixty-five 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 NDA: 202342

Tradename:
ESOMEPRAZOLE STRONTIUM
Applicant:
Hanmi Pharm Co Ltd
Ingredient:
esomeprazole strontium
Patents:0
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 52246-200-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52246-200-30)
ESOMEPRAZOLE STRONTIUM
esomeprazole strontium
CAPSULE, DELAYED RELEASE;ORAL 202342 NDA ParaPRO LLC 52246-400 52246-400-30 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52246-400-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength24.65MG
Approval Date:Aug 6, 2013TE:RLD:No

Summary 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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