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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078430

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NDA 078430 describes LACTULOSE, which is a drug marketed by Cumberland Pharms, Ani Pharms, Apotex Inc, Fresenius Kabi, Hi Tech Pharma, Morton Grove, Paco, Pharm Assoc, Vintage Pharms, Vistapharm, West-ward Pharms Int, Wockhardt Bio Ag, Bio-pharm Inc, Roxane, and Solvay, and is included in twenty 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 078430

Tradename:	LACTULOSE
Applicant:	Ani Pharms
Ingredient:	lactulose
Patents:	0
Therapeutic Class:	Gastrointestinal Agents
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 078430

Gastrointestinal Agents

Profile for product number 001

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

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