Details for New Drug Application (NDA): 209022
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NDA 209022 describes XHANCE, which is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the XHANCE profile page.
The generic ingredient in XHANCE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
The generic ingredient in XHANCE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 209022
| Tradename: | XHANCE |
| Applicant: | Optinose Us Inc |
| Ingredient: | fluticasone propionate |
| Patents: | 15 |
Pharmacology for NDA: 209022
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 209022
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022 | NDA | OptiNose US, Inc. | 71143-375 | 71143-375-01 | 1 BOTTLE in 1 CARTON (71143-375-01) / 120 SPRAY, METERED in 1 BOTTLE |
| XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022 | NDA | OptiNose US, Inc. | 71143-375 | 71143-375-98 | 1 BOTTLE in 1 CARTON (71143-375-98) / 28 SPRAY, METERED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.093MG | ||||
| Approval Date: | Sep 18, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF CHRONIC RHINOSINUSITIS WITHOUT NASAL POLYPS (CRSSNP) IN ADULTS | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Oct 20, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 30, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF DELIVERING FLUTICASONE PROPIONATE TO A NASAL AIRWAY | ||||||||
Expired US Patents for NDA 209022
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022-001 | Sep 18, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022-001 | Sep 18, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Optinose Us Inc | XHANCE | fluticasone propionate | SPRAY, METERED;NASAL | 209022-001 | Sep 18, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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