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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 209041

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NDA 209041 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 Inc, 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 209041

Tradename:	BUDESONIDE
Applicant:	Sciecure Pharma Inc
Ingredient:	budesonide
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 209041

Anti-Inflammatory Agents
Bronchodilator Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	3MG
Approval Date:	Sep 28, 2017	TE:		RLD:	No

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