Last Updated: November 8, 2026

Details for New Drug Application (NDA): 073160

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NDA 073160 describes LACTULOSE, which is a drug marketed by Apotex, Pai Holdings, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Pharmazone, Pharmobedient, Taro, Vistapharm Llc, Bajaj, Pai Holdings Pharm, Roxane, and Solvay, and is included in twenty-four NDAs. It is available from twenty-two suppliers. Additional details are available on the LACTULOSE profile page.

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

Summary for 073160

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

Medical Subject Heading (MeSH) Categories for 073160

Gastrointestinal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	10GM/15ML
Approval Date:	Aug 25, 1992	TE:		RLD:	No

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