FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | A213948 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mylan Inc. FDA-2017-P-6750 · 8 docket documents Mylan Inc. filed this citizen petition under 21 U.S.C. § 355 and 21 C.F.R. § 10.30 requesting that the FDA refrain from approving any ANDA for fluticasone propionate and salmeterol xinafoate inhalation powder relying on Advair Diskus as the reference listed drug unless the applicant uses single-batc | 505(q) Stay Request | 2017-12-07 | Denied | Mylan Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.61
per ea
Lowest NADAC/Unit
$1.14
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093751631FLUTICASONE-SALMETEROL 500-50 | $1.61 | EA | Generic | — | 2026-06-17 |
| 00093751831FLUTICASONE-SALMETEROL 250-50 | $1.32 | EA | Generic | — | 2026-06-17 |
| 00093751731FLUTICASONE-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.