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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205457

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NDA 205457 describes BUDESONIDE, which is a drug marketed by Padagis Israel, Amneal Pharms, Aurobindo Pharma Usa, Barr Labs Div Teva, Dr Reddys Labs Sa, Natco, Rising, Sciecure Pharma Inc, Zydus Pharms, Apotex, Cipla, Eugia Pharma, Impax Labs Inc, Lupin, Nephron, Sandoz, Sun Pharm, Teva Pharms, Teva Pharms Usa, Actavis Labs Fl Inc, and Mylan, and is included in twenty-one NDAs. It is available from thirty-three suppliers. Additional details are available on the BUDESONIDE profile page.

The generic ingredient in BUDESONIDE is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 205457

Tradename:	BUDESONIDE
Applicant:	Actavis Labs Fl Inc
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 205457

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 205457

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 205457

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUDESONIDE	budesonide	TABLET, EXTENDED RELEASE;ORAL	205457	ANDA	Actavis Pharma, Inc.	0591-2510	0591-2510-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	9MG
Approval Date:	Jul 3, 2018	TE:	AB	RLD:	No

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