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Details for New Drug Application (NDA): 077072
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NDA 077072 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. Sixteen suppliers are listed for this compound. 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. Sixteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.
Summary for 077072
| Tradename: | IPRATROPIUM BROMIDE |
| Applicant: | Landela Pharm |
| Ingredient: | ipratropium bromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 077072
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 0.02% | ||||
| Approval Date: | Jul 19, 2005 | TE: | AN | RLD: | No | ||||
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