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Details for New Drug Application (NDA): 205625
NDA 205625 describes ARNUITY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ARNUITY ELLIPTA profile page.
The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
Summary for 205625
| Tradename: | ARNUITY ELLIPTA |
| Applicant: | Glaxosmithkline |
| Ingredient: | fluticasone furoate |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205625
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 205625
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0874 | 0173-0874-10 | 1 INHALER in 1 CARTON (0173-0874-10) > 30 POWDER in 1 INHALER |
| ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0874 | 0173-0874-14 | 1 INHALER in 1 CARTON (0173-0874-14) > 14 POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH | ||||
| Approval Date: | Aug 20, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 17, 2021 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 3, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 3, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205625
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | Start Trial | Start Trial |
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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