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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fuji
Farmers Insurance
Express Scripts
Johnson and Johnson
McKesson
Harvard Business School
US Army
Moodys
Cerilliant
AstraZeneca

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090502

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NDA 090502 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, Bio-pharm Inc, Roxane, and Solvay, and is included in twenty NDAs. It is available from twenty 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. Twenty suppliers are listed for this compound. Additional details are available on the lactulose profile page.

Summary for 090502

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090502

Medical Subject Heading (MeSH) Categories for 090502

Suppliers and Packaging for NDA: 090502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LACTULOSE lactulose SOLUTION;ORAL, RECTAL 090502 ANDA Fresenius Kabi Austria GmbH 18124-002 18124-002-16 473 mL in 1 BOTTLE (18124-002-16)
LACTULOSE lactulose SOLUTION;ORAL, RECTAL 090502 ANDA Actavis Pharma, Inc. 45963-438 45963-438-64 473 mL in 1 BOTTLE (45963-438-64)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORAL, RECTALStrength10GM/15ML
Approval Date:Jan 25, 2012TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Baxter
Colorcon
Julphar
Johnson and Johnson
US Department of Justice
Cipla
Novartis
Healthtrust

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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