You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218083

✉ Email this page to a colleague

« Back to Dashboard

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 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.