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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Healthtrust
US Army
Fish and Richardson
US Department of Justice
Chubb
Express Scripts
Colorcon
Novartis
AstraZeneca

Generated: August 22, 2017

DrugPatentWatch Database Preview

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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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
LACTULOSE
lactulose
SOLUTION;ORAL, RECTAL 074077 ANDA Hi-Tech Pharmacal Co., Inc. 50383-795 50383-795-16 473 mL in 1 BOTTLE (50383-795-16)
LACTULOSE
lactulose
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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Serving 500+ biopharmaceutical companies globally:

Merck
Teva
AstraZeneca
QuintilesIMS
Accenture
Covington
Baxter
Cerilliant
Deloitte
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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