Last Updated: August 11, 2026

Details for New Drug Application (NDA): 201966

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NDA 201966 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, Mylan, and Teva Pharms Usa Inc, and is included in twenty-two NDAs. It is available from thirty suppliers. Additional details are available on the BUDESONIDE profile page.

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

Summary for 201966

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

Medical Subject Heading (MeSH) Categories for 201966

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;INHALATION			Strength	1MG/2ML
Approval Date:	Sep 27, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;INHALATION			Strength	0.5MG/2ML
Approval Date:	Sep 27, 2013	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;INHALATION			Strength	0.25MG/2ML
Approval Date:	Sep 27, 2013	TE:		RLD:	No

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