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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210525

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NDA 210525 describes PREDNISONE, which is a drug marketed by Hikma, Xttrium Labs Inc, Actavis Labs Fl Inc, Allied, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Endo Operations, 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, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Sandoz, 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 sixteen NDAs. It is available from forty-eight 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 210525

Tradename:	PREDNISONE
Applicant:	Geneyork Pharms
Ingredient:	prednisone
Patents:	0

Pharmacology for NDA: 210525

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 210525

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 210525

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISONE	prednisone	TABLET;ORAL	210525	ANDA	St. Mary's Medical Park Pharmacy	60760-615	60760-615-18	18 TABLET in 1 BOTTLE, PLASTIC (60760-615-18)
PREDNISONE	prednisone	TABLET;ORAL	210525	ANDA	St. Mary's Medical Park Pharmacy	60760-715	60760-715-12	12 TABLET in 1 BOTTLE, PLASTIC (60760-715-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 4, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Dec 4, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Dec 4, 2018	TE:		RLD:	No

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