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McKesson
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Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076664

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NDA 076664 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 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-two suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 076664
Tradename:IPRATROPIUM BROMIDE
Applicant:West-ward Pharms Int
Ingredient:ipratropium bromide
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076664
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 076664
Suppliers and Packaging for NDA: 076664
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076664 ANDA West-Ward Pharmaceuticals Corp. 0054-0045 N 0054-0045-44

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.021MG/SPRAY
Approval Date:Nov 5, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Dow
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