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Serving leading biopharmaceutical companies globally:

Medtronic
Chinese Patent Office
US Department of Justice
Federal Trade Commission
Covington
UBS
Healthtrust
Accenture
Baxter
US Army

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080358

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NDA 080358 describes PREDNISOLONE, which is a drug marketed by Apotex Inc, Hi Tech Pharma Co, Ivax Sub Teva Pharms, Nesher Pharms, Pharm Assoc, Teva Pharms, Vintage, Vistapharm, We Pharms, Wockhardt, Aurolife Pharma Llc, Barr, Bundy, Chartwell Rx, Elkins Sinn, Everylife, Ferrante, Heather, Impax Labs, Inwood Labs, Lannett, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Roxane, Sandoz, Sperti, Superpharm, Tablicaps, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Akorn, Bel Mar, Cent Pharms, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal Pharms, Edenbridge Pharms, Hi Tech Pharma, Medicis Pharms, Mission Pharma, Vintage Pharms, and Mylan Pharms Inc, and is included in eighty-two NDAs. It is available from fifteen suppliers. Additional details are available on the PREDNISOLONE profile page.

The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-six drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.

Summary for 080358

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Cipla
Harvard Business School
Covington
Daiichi Sankyo
Healthtrust
Boehringer Ingelheim
Chubb
Baxter

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