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Serving leading biopharmaceutical companies globally:

Moodys
Cerilliant
UBS
Farmers Insurance
Queensland Health
Cipla
Chinese Patent Office
Federal Trade Commission
US Army
Daiichi Sankyo

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089081

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NDA 089081 describes PRELONE, which is a drug marketed by Muro and Teva and is included in two NDAs. It is available from three suppliers. Additional details are available on the PRELONE profile page.

The generic ingredient in PRELONE is prednisolone. There are eighty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the prednisolone profile page.
Summary for 089081
Tradename:PRELONE
Applicant:Teva
Ingredient:prednisolone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 089081
Medical Subject Heading (MeSH) Categories for 089081
Suppliers and Packaging for NDA: 089081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRELONE prednisolone SYRUP;ORAL 089081 ANDA Teva Pharmaceuticals USA, Inc. 0093-6118 N 0093-6118-16
PRELONE prednisolone SYRUP;ORAL 089081 ANDA Aidarex Pharmaceuticals LLC 33261-475 N 33261-475-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength15MG/5ML
Approval Date:Feb 4, 1986TE:AARLD:No

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Daiichi Sankyo
Cipla
Fish and Richardson
US Department of Justice
Argus Health
Deloitte
Mallinckrodt
Citi
McKinsey

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