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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 207367

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NDA 207367 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 207367

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

Medical Subject Heading (MeSH) Categories for 207367

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	3MG
Approval Date:	Apr 7, 2017	TE:	AB	RLD:	No

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