AZELASTINE HYDROCHLORIDE | A216421 | APOTEX INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Bayer U.S. LLC FDA-2022-P-2397 · 32 docket documents Bayer U.S. LLC filed this citizen petition requesting that the FDA confirm it will impose a 30-month stay on approval of Apotex Inc.'s ANDA 216421 for azelastine hydrochloride nasal spray 205.5 mcg/spray OTC, which references Bayer's NDA 213872, arguing that all statutory prerequisites for the stay | 505(q) Stay Request | 2022-09-30 | Withdrawn | Bayer U.S. LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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