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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215105

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NDA 215105 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 215105

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

Pharmacology for NDA: 215105

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 215105

Bronchodilator Agents
Cholinergic Antagonists

Suppliers and Packaging for NDA: 215105

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IPRATROPIUM BROMIDE	ipratropium bromide	SPRAY, METERED;NASAL	215105	ANDA	Amneal Pharmaceuticals NY LLC	69238-2017	69238-2017-2	1 BOTTLE, SPRAY in 1 CARTON (69238-2017-2) / 165 SPRAY in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.042MG/SPRAY
Approval Date:	Aug 16, 2022	TE:	AB	RLD:	No

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