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Generated: April 22, 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, 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 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 N 66220-719-30
LACTULOSE lactulose FOR SOLUTION;ORAL 074712 ANDA Cumberland Pharmaceuticals Inc. 66220-729 N 66220-729-30

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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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Fuji
Dow
Mallinckrodt
Cipla
Cantor Fitzgerald
QuintilesIMS
Baxter
McKesson

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