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Last Updated: March 17, 2025

Details for New Drug Application (NDA): 217912

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NDA 217912 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Nephron, Norvium Bioscience, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, Hikma, Lupin, and Rubicon, and is included in twenty-seven NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

Summary for 217912

Tradename:	IPRATROPIUM BROMIDE
Applicant:	Lupin
Ingredient:	ipratropium bromide
Patents:	0

Medical Subject Heading (MeSH) Categories for 217912

Bronchodilator Agents
Cholinergic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.021MG/SPRAY
Approval Date:	Feb 7, 2025	TE:	AB	RLD:	No

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