Details for New Drug Application (NDA): 090502

NDA 090502 describes LACTULOSE, which is a drug marketed by Cumberland Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Vistapharm, Xttrium Labs Inc, Bajaj, Pai Holdings Pharm, Roxane, and Solvay, and is included in twenty-two NDAs. It is available from eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for 090502

Tradename:	LACTULOSE
Applicant:	Fresenius Kabi
Ingredient:	lactulose
Patents:	0

Pharmacology for NDA: 090502

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

Medical Subject Heading (MeSH) Categories for 090502

Gastrointestinal Agents

Suppliers and Packaging for NDA: 090502

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	090502	ANDA	Fresenius Kabi Austria GmbH	18124-002	18124-002-16	473 mL in 1 BOTTLE (18124-002-16)
LACTULOSE	lactulose	SOLUTION;ORAL, RECTAL	090502	ANDA	Actavis Pharma, Inc.	45963-438	45963-438-64	473 mL in 1 BOTTLE (45963-438-64)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL, RECTAL			Strength	10GM/15ML
Approval Date:	Jan 25, 2012	TE:	AA	RLD:	No

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