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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076291

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NDA 076291 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 seven 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 076291

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076291

Mechanism of ActionCholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 076291

Suppliers and Packaging for NDA: 076291

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 076291 ANDA Rebel Distributors Corp 21695-911 21695-911-30 1 POUCH in 1 CARTON (21695-911-30) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL
IPRATROPIUM BROMIDE ipratropium bromide SOLUTION;INHALATION 076291 ANDA Rebel Distributors Corp 21695-911 21695-911-25 1 POUCH in 1 CARTON (21695-911-25) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength0.02%
Approval Date:May 9, 2005TE:ANRLD:No


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