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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 076645

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NDA 076645 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 076645

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

Pharmacology for NDA: 076645

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

Medical Subject Heading (MeSH) Categories for 076645

Gastrointestinal Agents

Suppliers and Packaging for NDA: 076645

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	076645	ANDA	Bajaj Medical, LLC	61037-471	61037-471-02	236 mL in 1 BOTTLE (61037-471-02)
LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	076645	ANDA	Bajaj Medical, LLC	61037-471	61037-471-03	946 mL in 1 BOTTLE (61037-471-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL, RECTAL			Strength	10GM/15ML
Approval Date:	Jul 28, 2003	TE:	AA	RLD:	No

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