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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 076025


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NDA 076025 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 076025
Tradename:IPRATROPIUM BROMIDE
Applicant:Bausch
Ingredient:ipratropium bromide
Patents:0
Pharmacology for NDA: 076025
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 076025
Bronchodilator Agents
Cholinergic Antagonists
Suppliers and Packaging for NDA: 076025
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076025 ANDA Bausch & Lomb Incorporated 24208-398 24208-398-30 1 BOTTLE, SPRAY in 1 CARTON (24208-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076025 ANDA Oceanside Pharmaceuticals 68682-398 68682-398-30 1 BOTTLE, SPRAY in 1 CARTON (68682-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.021MG/SPRAY
Approval Date:Mar 31, 2003TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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