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Last Updated: May 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090503


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NDA 090503 describes LACTULOSE, which is a drug marketed by Cumberland Pharms, Ani Pharms, Fresenius Kabi, Hi Tech Pharma, Hikma, Lannett Co Inc, Lifepharma, Morton Grove, Paco, Pharm Assoc, Torrent, Vistapharm, Wockhardt Bio Ag, Xttrium Labs Inc, Bajaj, Roxane, and Solvay, and is included in twenty-two NDAs. It is available from fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.
Summary for 090503
Tradename:LACTULOSE
Applicant:Fresenius Kabi
Ingredient:lactulose
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090503
Medical Subject Heading (MeSH) Categories for 090503
Suppliers and Packaging for NDA: 090503
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACTULOSE lactulose SOLUTION;ORAL 090503 ANDA Actavis Pharma, Inc. 45963-439 45963-439-63 237 mL in 1 BOTTLE (45963-439-63)
LACTULOSE lactulose SOLUTION;ORAL 090503 ANDA Actavis Pharma, Inc. 45963-439 45963-439-65 946 mL in 1 BOTTLE (45963-439-65)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10GM/15ML
Approval Date:Jan 25, 2012TE:AARLD:No

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