Last Updated: November 8, 2026

Details for New Drug Application (NDA): 214297

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NDA 214297 describes METHYLPREDNISOLONE ACETATE, which is a drug marketed by Amneal, Caplin, Emerge Bioscience, Epic Pharma Llc, Eugia Pharma, Hikma, 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 seven suppliers. Additional details are available on the METHYLPREDNISOLONE ACETATE profile page.

The generic ingredient in METHYLPREDNISOLONE ACETATE is methylprednisolone acetate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

Summary for 214297

Tradename:	METHYLPREDNISOLONE ACETATE
Applicant:	Ph Health
Ingredient:	methylprednisolone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	40MG/ML
Approval Date:	Jan 21, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	80MG/ML
Approval Date:	Jan 21, 2022	TE:	AB	RLD:	No

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