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LACTULOSE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAI HOLDINGS · Approved 2025-03-14

Drug application

FDA Application #

ANDA217914

Application type

Abbreviated New Drug Application (Generic)

Brand name

LACTULOSE

Generic name

LACTULOSE

Active ingredients

LACTULOSE

Dosage form

FOR SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

PAI HOLDINGS

Manufacturer

PAI Holdings, LLC dba PAI Pharma

First approval

2025-03-14

Source

Authoritative

Drugs@FDA application overview

Machine

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