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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 040719

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NDA 040719 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Epic Pharma Llc, Eugia Pharma, Hikma, Hong Kong, Ph Health, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in eighteen NDAs. It is available from eight suppliers. Additional details are available on the METHYLPREDNISOLONE ACETATE profile page.

The generic ingredient in METHYLPREDNISOLONE ACETATE 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 040719

Tradename:	METHYLPREDNISOLONE ACETATE
Applicant:	Sandoz
Ingredient:	methylprednisolone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Jan 29, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/ML
Approval Date:	Jan 29, 2009	TE:	AB	RLD:	No

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