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. It is available from one supplier. 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. Ten 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. Ten 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 |
Pharmacology for NDA: 202049
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for 202049
Suppliers and Packaging for NDA: 202049
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRONCHITOL | mannitol | POWDER;INHALATION | 202049 | NDA | Arna Pharma Pty Ltd | 84639-212 | 84639-212-04 | 1 BLISTER PACK in 1 CARTON (84639-212-04) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01) |
| BRONCHITOL | mannitol | POWDER;INHALATION | 202049 | NDA | Arna Pharma Pty Ltd | 84639-212 | 84639-212-14 | 14 BLISTER PACK in 1 CARTON (84639-212-14) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01) |
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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