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Last Updated: April 2, 2026

Details for New Drug Application (NDA): 218858

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NDA 218858 describes LACTULOSE, which is a drug marketed by Cumberland Pharms, Pai Holdings, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Pharmobedient, Taro, Vistapharm Llc, Bajaj, Pai Holdings Pharm, Roxane, Sciegen Pharms, and Solvay, and is included in twenty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the LACTULOSE profile page.

The generic ingredient in LACTULOSE is lactulose. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for 218858

Tradename:	LACTULOSE
Applicant:	Taro
Ingredient:	lactulose
Patents:	0

Pharmacology for NDA: 218858

Mechanism of Action	Acidifying Activity Osmotic Activity
Physiological Effect	Stimulation Large Intestine Fluid/Electrolyte Secretion

Medical Subject Heading (MeSH) Categories for 218858

Gastrointestinal Agents

Suppliers and Packaging for NDA: 218858

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACTULOSE	lactulose	SOLUTION;ORAL	218858	ANDA	Sun Pharmaceutical Industries, Inc.	51672-4243	51672-4243-9	1 BOTTLE in 1 CARTON (51672-4243-9) / 473 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10GM/15ML
Approval Date:	Dec 13, 2024	TE:	AA	RLD:	No

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