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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Cerilliant
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074712

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NDA 074712 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 074712
Tradename:LACTULOSE
Applicant:Cumberland Pharms
Ingredient:lactulose
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074712
Medical Subject Heading (MeSH) Categories for 074712
Suppliers and Packaging for NDA: 074712
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACTULOSE lactulose FOR SOLUTION;ORAL 074712 ANDA Cumberland Pharmaceuticals Inc. 66220-719 66220-719-30 30 POUCH in 1 CARTON (66220-719-30) > 10 g in 1 POUCH (66220-719-01)
LACTULOSE lactulose FOR SOLUTION;ORAL 074712 ANDA Cumberland Pharmaceuticals Inc. 66220-729 66220-729-30 30 POUCH in 1 CARTON (66220-729-30) > 20 g in 1 POUCH (66220-729-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength10GM/PACKET
Approval Date:Dec 10, 1997TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrength20GM/PACKET
Approval Date:Dec 10, 1997TE:RLD:No

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Mallinckrodt
Accenture
Daiichi Sankyo
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Merck
McKinsey
US Army
Healthtrust
Boehringer Ingelheim

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