FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | A214464 | RESPIRENT PHARMACEUTICALS CO LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Mylan Inc. FDA-2017-P-6750 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.
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