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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 088497

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NDA 088497 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Amneal, Chartwell Rx, Duramed Pharms Barr, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Ph Health, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Epic Pharma Llc, Eugia Pharma, Hikma, Hong Kong, 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 NDAs. It is available from twenty-six suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.

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

Summary for 088497

Tradename:	METHYLPREDNISOLONE
Applicant:	Duramed Pharms Barr
Ingredient:	methylprednisolone
Patents:	0

Medical Subject Heading (MeSH) Categories for 088497

Anti-Inflammatory Agents
Antiemetics
Glucocorticoids
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Feb 21, 1984	TE:		RLD:	No

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