Last Updated: August 25, 2026

Details for New Drug Application (NDA): 216667

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NDA 216667 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 216667

Tradename:	BUDESONIDE
Applicant:	Eugia Pharma
Ingredient:	budesonide
Patents:	0

Pharmacology for NDA: 216667

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216667

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Suppliers and Packaging for NDA: 216667

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BUDESONIDE	budesonide	SUSPENSION;INHALATION	216667	ANDA	Aurobindo Pharma Limited	59651-585	59651-585-30	6 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;INHALATION			Strength	0.5MG/2ML
Approval Date:	Nov 29, 2023	TE:	AN	RLD:	No

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