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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 219145

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NDA 219145 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Caplin, 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 nineteen NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for 219145

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/ML
Approval Date:	Apr 16, 2025	TE:	AB	RLD:	No

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