Last Updated: June 24, 2026

Details for New Drug Application (NDA): 219509

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NDA 219509 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, Tp Anda Holdings, 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, Amneal, Lupin, Alcon Pharms Ltd, Bausch And Lomb, Sola Barnes Hind, Amneal Pharms, Bausch, Edenbridge Pharms, Mission Pharma, Ph Health, Pharmobedient, and Vintage Pharms, and is included in eighty-nine NDAs. It is available from ten 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 219509

Tradename:	PREDNISOLONE
Applicant:	Tp Anda Holdings
Ingredient:	prednisolone
Patents:	0

Medical Subject Heading (MeSH) Categories for 219509

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	15MG/5ML
Approval Date:	Jun 23, 2025	TE:	AA	RLD:	No

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