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Last Updated: April 15, 2026

Details for New Drug Application (NDA): 207481

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NDA 207481 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, Praxgen, Rising, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Caplin, 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-one 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. Eleven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for 207481

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

Medical Subject Heading (MeSH) Categories for 207481

Anti-Inflammatory Agents
Antiemetics
Glucocorticoids
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Sep 21, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	8MG
Approval Date:	Sep 21, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	16MG
Approval Date:	Sep 21, 2021	TE:		RLD:	No

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