Last Updated: September 24, 2026

Details for New Drug Application (NDA): 218083

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NDA 218083 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 218083

Tradename:	PREDNISOLONE
Applicant:	Zhejiang Xianju
Ingredient:	prednisolone
Patents:	0

Pharmacology for NDA: 218083

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 218083

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 218083

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE	prednisolone	TABLET;ORAL	218083	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-160	42658-160-05	100 TABLET in 1 BOTTLE (42658-160-05)
PREDNISOLONE	prednisolone	TABLET;ORAL	218083	ANDA	Zhejiang Xianju Pharmaceutical Co., Ltd.	60722-5011	60722-5011-0	100 TABLET in 1 BOTTLE (60722-5011-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 2, 2024	TE:	AB	RLD:	No

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