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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078949

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NDA 078949 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-four 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-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.

Summary for 078949

Tradename:	BUDESONIDE
Applicant:	Apotex
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 078949

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 078949

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 078949

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUDESONIDE	budesonide	SPRAY, METERED;NASAL	078949	ANDA	Walgreens	0363-0048	0363-0048-01	1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (0363-0048-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
BUDESONIDE	budesonide	SPRAY, METERED;NASAL	078949	ANDA	Rugby Laboratories	0536-1112	0536-1112-48	1 BOTTLE, SPRAY in 1 CARTON (0536-1112-48) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	SPRAY, METERED;NASAL			Strength	0.032MG/SPRAY
Approval Date:	Nov 20, 2015	TE:		RLD:	No

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