Last Updated: November 13, 2026

Details for New Drug Application (NDA): 215671

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NDA 215671 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, 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, Pharmazone, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Quagen, 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 eleven NDAs. It is available from forty-five suppliers. Additional details are available on the PREDNISONE profile page.

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

Summary for 215671

Tradename:	PREDNISONE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	prednisone
Patents:	0

Pharmacology for NDA: 215671

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 215671

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 215671

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISONE	prednisone	TABLET;ORAL	215671	ANDA	Aurobindo Pharma Limited	59651-484	59651-484-01	100 TABLET in 1 BOTTLE (59651-484-01)
PREDNISONE	prednisone	TABLET;ORAL	215671	ANDA	Aurobindo Pharma Limited	59651-484	59651-484-78	10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 16, 2021	TE:	AB	RLD:	No

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