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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 080352

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NDA 080352 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 080352

Tradename:	PREDNISONE
Applicant:	Hikma
Ingredient:	prednisone
Patents:	0

Pharmacology for NDA: 080352

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 080352

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 080352

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISONE	prednisone	TABLET;ORAL	080352	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0017	0054-0017-20	10 BLISTER PACK in 1 CARTON (0054-0017-20) / 10 TABLET in 1 BLISTER PACK
PREDNISONE	prednisone	TABLET;ORAL	080352	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0017	0054-0017-25	100 TABLET in 1 BOTTLE, PLASTIC (0054-0017-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Apr 22, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Apr 22, 1982	TE:	AB	RLD:	Yes

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