DEXLANSOPRAZOLE | N208056 | TAKEDA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alliance For Natural Health USA FDA-2020-P-1540 · 5 docket documents Alliance for Natural Health USA filed this citizen petition requesting that the Food and Drug Administration issue a regulation requiring all manufacturers of proton pump inhibitor medications, including omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, and dexlansoprazole, to expan | 505(q) | 2020-06-11 | Denied | Alliance For Natural Health USA |
Takeda Pharmaceuticals U.S.A., Inc. - Citizen Petition FDA-2013-P-0198 · 4 docket documents Takeda Pharmaceuticals U.S.A., Inc. filed this citizen petition under 21 USC 355 and 21 CFR 10.30 on February 15, 2013, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) referencing DEXILANT (dexlansoprazole) delayed-release capsules unless the applicant prov | 505(q) | 2013-03-08 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.