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Details for New Drug Application (NDA): 085416

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NDA 085416 describes PREDNISOLONE, which is a drug marketed by Hi Tech Pharma Co, Marshall Pharma, Pvt Form, Wockhardt, Watson Labs, Teva Pharms, Phoenix Labs Ny, Alpharma, Nesher Pharms, West Ward, Elkins Sinn, Purepac Pharm, Barr, Heather, Roxane, Lannett, Vitarine, Valeant Pharm Intl, Everylife, Sandoz, Perrigo, Whiteworth Town Plsn, Inwood Labs, Panray, Sperti, Ferrante, Apotex Inc, Tablicaps, Aurolife Pharma Llc, Vintage, Bundy, Ivax Sub Teva Pharms, Impax Labs, UDL, We Pharms, Superpharm, Teva, Pharm Assoc, Cent Pharms, Akorn, Bel Mar, Vintage Pharms, Alcon Pharms Ltd, Amneal Pharms, Medicis Pharms, Bausch And Lomb, Sola Barnes Hind, Mylan Pharms Inc, Hi Tech Pharma, Paddock Llc, and Mission Pharma, and is included in eighty-one 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-four drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.

Summary for NDA: 085416

Summary for product number 001

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

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