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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 074077

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NDA 074077 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 074077

Tradename:	LACTULOSE
Applicant:	Pai Holdings Pharm
Ingredient:	lactulose
Patents:	0

Medical Subject Heading (MeSH) Categories for 074077

Gastrointestinal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL, RECTAL			Strength	10GM/15ML
Approval Date:	Jul 3, 1995	TE:		RLD:	No

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