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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Harvard Business School

Last Updated: May 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 084439

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NDA 084439 describes PREDNISOLONE, which is a drug marketed by Hi Tech Pharma Co, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Teva Pharms, Vistapharm, We Pharms, Wockhardt Bio Ag, Aurolife Pharma Llc, Barr, Bundy, Chartwell Rx, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Lannett, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Roxane, 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, Vintage Pharms, and Mylan Pharms Inc, and is included in eighty-three NDAs. It is available from nine suppliers. Additional details are available on the PREDNISOLONE profile page.

The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.
Summary for 084439
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 084439

Profile for product number 001

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

Profile for product number 002

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

Profile 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:

Express Scripts
Boehringer Ingelheim

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