← FDA Drug Approvals (Drugs@FDA)

PANTOPRAZOLE SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DEXCEL · Approved 2023-06-16

Drug application

FDA Application #

ANDA216247

Application type

Abbreviated New Drug Application (Generic)

Brand name

PANTOPRAZOLE SODIUM

Generic name

PANTOPRAZOLE SODIUM

Active ingredients

PANTOPRAZOLE SODIUM

Dosage form

FOR SUSPENSION, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

DEXCEL

Manufacturer

Edenbridge Pharmaceuticals LLC.

First approval

2023-06-16

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown