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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
QuintilesIMS
Covington
Fuji
Farmers Insurance
US Army
Colorcon
McKinsey

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090502

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NDA 090502 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 twenty 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 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
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090502
Medical Subject Heading (MeSH) Categories for 090502
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 N 18124-002-16
LACTULOSE lactulose SOLUTION;ORAL, RECTAL 090502 ANDA Actavis Pharma, Inc. 45963-438 N 45963-438-64

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORAL, RECTALStrength10GM/15ML
Approval Date:Jan 25, 2012TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Baxter
Fuji
Covington
US Army
Colorcon
Dow
Deloitte
Mallinckrodt

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