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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Cantor Fitzgerald
Express Scripts
Julphar
Fuji
US Army
Moodys
Federal Trade Commission
Accenture

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075993

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NDA 075993 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, 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 075993

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075993

Medical Subject Heading (MeSH) Categories for 075993

Suppliers and Packaging for NDA: 075993

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACTULOSE lactulose SOLUTION;ORAL 075993 ANDA Qualitest Pharmaceuticals 0603-1378 0603-1378-58 473 mL in 1 BOTTLE (0603-1378-58)
LACTULOSE lactulose SOLUTION;ORAL 075993 ANDA Qualitest Pharmaceuticals 0603-1378 0603-1378-59 946 mL in 1 BOTTLE (0603-1378-59)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10GM/15ML
Approval Date:Jul 26, 2001TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Novartis
Teva
Harvard Business School
Citi
Cerilliant
Dow
McKinsey
Johnson and Johnson

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