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Last Updated: March 25, 2026

Details for New Drug Application (NDA): 219477

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NDA 219477 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for 219477

Tradename:	PREDNISONE
Applicant:	Dr Reddys
Ingredient:	prednisone
Patents:	0

Pharmacology for NDA: 219477

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 219477

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 219477

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISONE	prednisone	TABLET, DELAYED RELEASE;ORAL	219477	ANDA	Dr. Reddys Laboratories Inc.	43598-886	43598-886-01	1 BOTTLE in 1 CARTON (43598-886-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE
PREDNISONE	prednisone	TABLET, DELAYED RELEASE;ORAL	219477	ANDA	Dr. Reddys Laboratories Inc.	43598-886	43598-886-30	1 BOTTLE in 1 CARTON (43598-886-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	1MG
Approval Date:	Oct 1, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	2MG
Approval Date:	Oct 1, 2025	TE:		RLD:	No

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