Drug application
ANORO ELLIPTA (UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE)
Drugs@FDA NDA 203975 · GLAXOSMITHKLINE
Key facts
| Drug name | ANORO ELLIPTA |
|---|---|
| Active ingredients | UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE |
| Application type | NDA |
| Application number | 203975 |
| Company | GLAXOSMITHKLINE |
| Dosage forms | POWDER, INHALATION |
| Strength | EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 1 - New Molecular Entity and Type 4 - New Combination |
| Latest submission status date | Dec 18, 2013 |
At a glance
- 1–9 Submissions
- 1–9 Supplements
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: