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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211575

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NDA 211575 describes PREDNISONE, which is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, Dr Reddys, Aiping Pharm Inc, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Everylife, Ferrante, Geneyork Pharms, Halsey, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Ph Health, Pharmavite, Phoenix Labs Ny, Pointview Hldings, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and ten NDAs. It is available from forty-seven suppliers. Additional details are available on the PREDNISONE profile page.

The generic ingredient in PREDNISONE is prednisone. There are sixteen drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for 211575

Tradename:	PREDNISONE
Applicant:	Novitium Pharma
Ingredient:	prednisone
Patents:	0

Pharmacology for NDA: 211575

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 211575

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 211575

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISONE	prednisone	TABLET;ORAL	211575	ANDA	Marlex Pharmaceuticals, Inc.	10135-775	10135-775-01	100 TABLET in 1 BOTTLE (10135-775-01)
PREDNISONE	prednisone	TABLET;ORAL	211575	ANDA	Marlex Pharmaceuticals, Inc.	10135-776	10135-776-01	100 TABLET in 1 BOTTLE (10135-776-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Nov 15, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Nov 15, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 15, 2019	TE:	AB	RLD:	No

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