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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 085084

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NDA 085084 describes PREDNISONE, which is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, Allied, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Endo Operations, Everylife, Ferrante, Geneyork Pharms, Halsey, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Sandoz, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and sixteen NDAs. It is available from forty-nine suppliers. Additional details are available on the PREDNISONE profile page.

The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for 085084

Tradename:	PREDNISONE
Applicant:	Watson Labs
Ingredient:	prednisone
Patents:	0

Medical Subject Heading (MeSH) Categories for 085084

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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