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Last Updated: March 28, 2024

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, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Fresenius Kabi, Hikma, Lannett Co Inc, Morton Grove, Paco, Pharm Assoc, Vistapharm, Xttrium Labs Inc, Bajaj, Pai Holdings Pharm, Roxane, and Solvay, and is included in twenty-two 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 075993
Tradename:LACTULOSE
Applicant:Lannett Co Inc
Ingredient:lactulose
Patents:0
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 Lannett Company, Inc. 0527-5125 0527-5125-68 237 mL in 1 BOTTLE (0527-5125-68)
LACTULOSE lactulose SOLUTION;ORAL 075993 ANDA Lannett Company, Inc. 0527-5125 0527-5125-70 473 mL in 1 BOTTLE (0527-5125-70)

Profile for product number 001

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

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