← FDA Drug Approvals (Drugs@FDA)

DEXLANSOPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2017-04-19

Drug application

FDA Application #

ANDA202294

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

PH HEALTH

Manufacturer

Par Health USA, LLC

First approval

2017-04-19

Source

Authoritative

Drugs@FDA application overview

Machine

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