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Last Updated: April 6, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076103

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NDA 076103 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 Pharm, Teva Pharms Usa, Watson Labs, Bausch And Lomb, and Hikma, and is included in twenty-one NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 076103
Applicant:Bausch And Lomb
Ingredient:ipratropium bromide
Formulation / Manufacturing:see details
Pharmacology for NDA: 076103
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for 076103
Suppliers and Packaging for NDA: 076103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IPRATROPIUM BROMIDE ipratropium bromide SPRAY, METERED;NASAL 076103 ANDA Bausch & Lomb Incorporated 24208-399 24208-399-15 1 BOTTLE, SPRAY in 1 CARTON (24208-399-15) > 165 SPRAY, METERED in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.042MG/SPRAY
Approval Date:Mar 31, 2003TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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