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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 080531

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NDA 080531 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 Ltd, Alcon Pharms Ltd, Bausch And Lomb, 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 eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.

Summary for 080531

Tradename:	PREDNISOLONE
Applicant:	Chartwell Molecular
Ingredient:	prednisolone
Patents:	0

Pharmacology for NDA: 080531

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 080531

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 080531

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE	prednisolone	TABLET;ORAL	080531	ANDA	Chartwell RX, LLC	62135-437	62135-437-30	30 TABLET in 1 BOTTLE (62135-437-30)

Profile for product number 002

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

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