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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 three 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. Three suppliers are listed for this compound. Additional details are available on the esomeprazole strontium profile page.

Summary for NDA: 202342

Hanmi Pharm Co Ltd
esomeprazole strontium

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
CAPSULE, DELAYED RELEASE;ORAL 202342 NDA Amneal Pharmaceuticals, LLC 53746-955 53746-955-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-955-03)
esomeprazole strontium
CAPSULE, DELAYED RELEASE;ORAL 202342 NDA Amneal Pharmaceuticals, LLC 53746-957 53746-957-03 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53746-957-03)

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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