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Federal Trade Commission
Farmers Insurance
US Department of Justice
Cerilliant
US Army
Covington
Johnson and Johnson
Mallinckrodt
Daiichi Sankyo

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074077

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NDA 074077 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 074077
Tradename:LACTULOSE
Applicant:Hi Tech Pharma
Ingredient:lactulose
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074077
Medical Subject Heading (MeSH) Categories for 074077
Suppliers and Packaging for NDA: 074077
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACTULOSE lactulose SOLUTION;ORAL, RECTAL 074077 ANDA Hi-Tech Pharmacal Co., Inc. 50383-795 N 50383-795-16
LACTULOSE lactulose SOLUTION;ORAL, RECTAL 074077 ANDA Hi-Tech Pharmacal Co., Inc. 50383-795 N 50383-795-64

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORAL, RECTALStrength10GM/15ML
Approval Date:Jul 3, 1995TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
McKinsey
Queensland Health
Moodys
Teva
Argus Health
Merck
Chinese Patent Office

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