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Generated: April 26, 2017

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Details for New Drug Application (NDA): 074077

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NDA 074077 describes LACTULOSE, which is a drug marketed by Morton Grove, Fresenius Kabi, Solvay, Apotex Inc, Cumberland Pharms, Pharm Assoc, Ani Pharms, Paco, Vistapharm, Bio-pharm Inc, Hi Tech Pharma, Roxane, West-ward Pharms Int, and Vintage Pharms, and is included in twenty NDAs. It is available from nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for NDA: 074077

Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074077

Suppliers and Packaging for NDA: 074077

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL, RECTAL 074077 ANDA Hi-Tech Pharmacal Co., Inc. 50383-795 50383-795-16 473 mL in 1 BOTTLE (50383-795-16)
SOLUTION;ORAL, RECTAL 074077 ANDA Hi-Tech Pharmacal Co., Inc. 50383-795 50383-795-64 1893 mL in 1 BOTTLE (50383-795-64)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORAL, RECTALStrength10GM/15ML
Approval Date:Jul 3, 1995TE:AARLD:No

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