Last Updated: May 3, 2026

Details for New Drug Application (NDA): 217953

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NDA 217953 describes IPRATROPIUM BROMIDE, which is a drug marketed by Armstrong Pharms, 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-eight NDAs. It is available from twenty-one 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-two suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

Summary for 217953

Tradename:	IPRATROPIUM BROMIDE
Applicant:	Armstrong Pharms
Ingredient:	ipratropium bromide
Patents:	0

Pharmacology for NDA: 217953

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 217953

Bronchodilator Agents
Cholinergic Antagonists

Suppliers and Packaging for NDA: 217953

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IPRATROPIUM BROMIDE	ipratropium bromide	AEROSOL, METERED;INHALATION	217953	ANDA	Armstrong Pharmaceuticals, Inc.	17270-0401	17270-0401-0	1 CANISTER in 1 CARTON (17270-0401-0) / 200 AEROSOL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.021MG/INH
Approval Date:	Feb 23, 2026	TE:	AB	RLD:	No

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