Last Updated: November 8, 2026

Details for New Drug Application (NDA): 085650

« Back to Dashboard

NDA 085650 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Amneal, Chartwell Rx, Duramed Pharms Barr, Heather, Ingenus Pharms Llc, Jubilant Cadista, Par Pharm, Ph Health, Quagen, Rising, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Caplin, Emerge Bioscience, Epic Pharma Llc, Eugia Pharma, Hikma, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in seventy-one NDAs. It is available from twenty-four suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.

The generic ingredient in METHYLPREDNISOLONE is methylprednisolone acetate. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for 085650

Tradename:	METHYLPREDNISOLONE
Applicant:	Heather
Ingredient:	methylprednisolone
Patents:	0

Medical Subject Heading (MeSH) Categories for 085650

Anti-Inflammatory Agents
Antiemetics
Glucocorticoids
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		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.