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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 075552

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NDA 075552 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Pharmobedient, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, Hikma, Lupin, and Rubicon Research, and is included in twenty-seven NDAs. It is available from twenty suppliers. Additional details are available on the IPRATROPIUM BROMIDE profile page.

The generic ingredient in IPRATROPIUM BROMIDE is ipratropium bromide. There are eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

Summary for 075552

Tradename:	IPRATROPIUM BROMIDE
Applicant:	Aurobindo Pharma Usa
Ingredient:	ipratropium bromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 075552

Bronchodilator Agents
Cholinergic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.021MG/SPRAY
Approval Date:	Mar 31, 2003	TE:		RLD:	No

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