Details for New Drug Application (NDA): 202049
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NDA 202049 describes BRONCHITOL, which is a drug marketed by Pharmaxis Europe and is included in one NDA. Additional details are available on the BRONCHITOL profile page.
The generic ingredient in BRONCHITOL is mannitol. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.
The generic ingredient in BRONCHITOL is mannitol. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 202049
| Tradename: | BRONCHITOL |
| Applicant: | Pharmaxis Europe |
| Ingredient: | mannitol |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 202049
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 40MG | ||||
| Approval Date: | Oct 30, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 30, 2027 | ||||||||
| Regulatory Exclusivity Use: | ADD-ON MAINTENANCE THERAPY TO IMPROVE PULMONARY FUNCTION IN ADULT PATIENTS 18 YEARS OF AGE AND OLDER WITH CYSTIC FIBROSIS AND WHO HAVE PASSED THE BRONCHITOL TOLERANCE TEST | ||||||||
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