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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 074755


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NDA 074755 describes IPRATROPIUM BROMIDE, which is a drug marketed by Actavis Mid Atlantic, Apotex Inc, Bausch, Landela Pharm, Luoxin Aurovitas, Mylan Speciality Lp, Nephron, Ritedose Corp, Roxane, Sun Pharm, Teva Pharms Usa, Watson Labs, Zennova, Amneal, Aurobindo Pharma Usa, and Hikma, and is included in twenty-three NDAs. It is available from eighteen 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 074755
Tradename:IPRATROPIUM BROMIDE
Applicant:Mylan Speciality Lp
Ingredient:ipratropium bromide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074755

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrength0.02%
Approval Date:Jan 10, 1997TE:RLD:No

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