Last Updated: September 24, 2026

Details for New Drug Application (NDA): 080748

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NDA 080748 describes PREDNISOLONE, which is a drug marketed by Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Tp Anda Holdings, We Pharms, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Zhejiang Xianju, Bel Mar, Cent Pharms, Epic Pharma Llc, Amneal, Lupin, Alcon Pharms Ltd, Bausch And Lomb, Bausch And Lomb Inc, Sola Barnes Hind, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Ph Health, Pharmobedient, and Vintage Pharms, and is included in eighty-nine NDAs. It is available from eleven suppliers. Additional details are available on the PREDNISOLONE profile page.

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

Summary for 080748

Tradename:	PREDNISOLONE
Applicant:	Inwood Labs
Ingredient:	prednisolone
Patents:	0

Medical Subject Heading (MeSH) Categories for 080748

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Profile for product number 001

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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