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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078430

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NDA 078430 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 Inc, 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 078430

Tradename:	LACTULOSE
Applicant:	Ani Pharms
Ingredient:	lactulose
Patents:	0

Medical Subject Heading (MeSH) Categories for 078430

Gastrointestinal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	10GM/15ML
Approval Date:	Nov 28, 2007	TE:		RLD:	No

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