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RABEPRAZOLE SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA USA · Approved 2017-02-17

Drug application

FDA Application #

ANDA205761

Application type

Abbreviated New Drug Application (Generic)

Brand name

RABEPRAZOLE SODIUM

Generic name

RABEPRAZOLE SODIUM

Active ingredients

RABEPRAZOLE SODIUM

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA USA

Manufacturer

Aurobindo Pharma Limited

First approval

2017-02-17

Source

Authoritative

Drugs@FDA application overview

Machine

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