FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | N021077 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sandoz Inc FDA-2016-P-3356 · 18 docket documents Sandoz Inc. filed this citizen petition under 21 C.F.R. §§ 10.25, 10.30 and Sections 505(j) and 505(q) of the FDCA requesting that the FDA refrain from approving any ANDA referencing Advair Diskus 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) as the reference listed | 505(q) | 2016-10-17 | Denied | Sandoz Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$4.23
per ea
Lowest NADAC/Unit
$1.14
per ea
Brand NDCs
3
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00173069700ADVAIR 500-50 DISKUS | $4.23 | EA | Brand | $1.61 | 2026-06-17 |
| 00173069600ADVAIR 250-50 DISKUS | $3.12 | EA | Brand | $1.32 | 2026-06-17 |
| 00173069500ADVAIR 100-50 DISKUS | $2.49 | EA | Brand | $1.14 | 2026-06-17 |
| 66993058697FLUTICASONE-SALMETEROL 500-50 | $1.61 | EA | Generic | — | 2026-06-17 |
| 66993058597FLUTICASONE-SALMETEROL 250-50 | $1.32 | EA | Generic | — | 2026-06-17 |
| 66993058497FLUTICASONE-SALMETEROL 100-50 | $1.14 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.