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DEXLANSOPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TWI PHARMS · Approved 2022-09-16

Drug application

FDA Application #

ANDA202666

Application type

Abbreviated New Drug Application (Generic)

Brand name

DEXLANSOPRAZOLE

Generic name

DEXLANSOPRAZOLE

Active ingredients

DEXLANSOPRAZOLE

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

TWI PHARMS

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2022-09-16

Source

Authoritative

Drugs@FDA application overview

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