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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 040401

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NDA 040401 describes PREDNISOLONE, which is a drug marketed by Chartwell Rx, Hikma, Ivax Sub Teva Pharms, Lannett Co Inc, Nesher Pharms, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, We Pharms, Aurobindo Pharma Ltd, Barr, Bundy, Chartwell Molecular, Elkins Sinn, Everylife, Ferrante, Fosun Pharma, Heather, Impax Labs, Inwood Labs, Marshall Pharma, Panray, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rising, Roxane, Sperti, Superpharm, Tablicaps, Teva, UDL, Valeant Pharm Intl, Vitarine, Watson Labs, West Ward, Whiteworth Town Plsn, Zhejiang Xianju, Bel Mar, Cent Pharms, Epic Pharma Llc, Lupin Ltd, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal, Amneal Pharms, Bausch, Edenbridge Pharms, Endo Operations, Mission Pharma, Vintage Pharms, and Xttrium Labs Inc, and is included in eighty-seven NDAs. It is available from nine suppliers. Additional details are available on the PREDNISOLONE profile page.

The generic ingredient in PREDNISOLONE is prednisolone tebutate. There are eighty-eight drug master file entries for this compound. Additional details are available on the prednisolone tebutate profile page.

Summary for 040401

Tradename:	PREDNISOLONE
Applicant:	Hikma
Ingredient:	prednisolone
Patents:	0

Pharmacology for NDA: 040401

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 040401

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Suppliers and Packaging for NDA: 040401

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREDNISOLONE	prednisolone	SYRUP;ORAL	040401	ANDA	Proficient Rx LP	63187-466	63187-466-64	1 BOTTLE in 1 CARTON (63187-466-64) / 240 mL in 1 BOTTLE
PREDNISOLONE	prednisolone	SYRUP;ORAL	040401	ANDA	RedPharm Drug, Inc.	67296-1656	67296-1656-6	60 mL in 1 BOTTLE (67296-1656-6)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	15MG/5ML
Approval Date:	Feb 27, 2003	TE:		RLD:	No

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