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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 212262

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NDA 212262 describes METHYLPREDNISOLONE, which is a drug marketed by Elkins Sinn, Organon Usa Inc, Amneal, Chartwell Rx, Duramed Pharms Barr, Endo Operations, Heather, Invatech, Jubilant Cadista, Novast Labs, Par Pharm, Praxgen, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Teva Pharms Usa, Wilshire Pharms Inc, Abraxis Pharm, Bedford Labs, Fresenius Kabi Usa, Hikma, Intl Medication, Teva Parenteral, and Tianjin Kingyork, and is included in sixty-nine NDAs. It is available from twenty-eight 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. Twelve suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for 212262

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

Medical Subject Heading (MeSH) Categories for 212262

Anti-Inflammatory Agents
Antiemetics
Glucocorticoids
Neuroprotective Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Jun 27, 2019	TE:		RLD:	No

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