Last Updated: November 8, 2026

Details for New Drug Application (NDA): 040183

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NDA 040183 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, Quagen, Rising, Sandoz, Tianjin Tianyao, Watson Labs, Zydus Pharms, Caplin, Emerge Bioscience, Epic Pharma Llc, Eugia Pharma, Hikma, 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-four suppliers. Additional details are available on the METHYLPREDNISOLONE profile page.

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

Summary for 040183

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

Pharmacology for NDA: 040183

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 040183

Anti-Inflammatory Agents
Antiemetics
Glucocorticoids
Neuroprotective Agents

Suppliers and Packaging for NDA: 040183

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	040183	ANDA	Par Health USA, LLC	0603-4593	0603-4593-15	1 DOSE PACK in 1 CARTON (0603-4593-15) / 21 TABLET in 1 DOSE PACK
METHYLPREDNISOLONE	methylprednisolone	TABLET;ORAL	040183	ANDA	Par Health USA, LLC	0603-4593	0603-4593-21	100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Dec 22, 1998	TE:	AB	RLD:	No

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