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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076598

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NDA 076598 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Bausch And Lomb Inc, Landela Pharm, Mylan Speciality Lp, Nephron, Pharmascience Inc, Ritedose Corp, Roxane, Sun Pharma Global, Teva Pharms Usa, Watson Labs, Bausch And Lomb, and West-ward Pharms Int, and is included in twenty-one NDAs. It is available from seventeen 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 076598
Applicant:West-ward Pharms Int
Ingredient:ipratropium bromide
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076598
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 076598
Suppliers and Packaging for NDA: 076598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076598 ANDA West-Ward Pharmaceuticals Corp. 0054-0046 N 0054-0046-41

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.042MG/SPRAY
Approval Date:Nov 5, 2003TE:ABRLD:No

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