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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 202294


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NDA 202294 describes DEXLANSOPRAZOLE, which is a drug marketed by Alembic, Mylan, Ph Health, and Twi Pharms, and is included in four NDAs. It is available from nine suppliers. Additional details are available on the DEXLANSOPRAZOLE profile page.

The generic ingredient in DEXLANSOPRAZOLE is dexlansoprazole. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
Summary for 202294
Tradename:DEXLANSOPRAZOLE
Applicant:Ph Health
Ingredient:dexlansoprazole
Patents:0
Pharmacology for NDA: 202294
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 202294
Anti-Ulcer Agents
Proton Pump Inhibitors
Suppliers and Packaging for NDA: 202294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202294 ANDA ENDO USA, Inc. 49884-147 49884-147-11 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-147-11)
DEXLANSOPRAZOLE dexlansoprazole CAPSULE, DELAYED RELEASE;ORAL 202294 ANDA ENDO USA, Inc. 49884-148 49884-148-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49884-148-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength60MG
Approval Date:Apr 19, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength30MG
Approval Date:Jun 16, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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