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 two suppliers. Additional details are available on the ARNUITY ELLIPTA profile page.
The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There is one drug master file entry for this compound. Four 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 is one drug master file entry for this compound. Four 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: | 0 |
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 | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.2MG/INH | ||||
| Approval Date: | Aug 20, 2014 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.05MG/INH | ||||
| Approval Date: | May 17, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971 | ||||||||
Expired US Patents for NDA 205625
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