PENICILLAMINE | N019853 | VALEANT PHARMACEUTICALS INTERNATIONAL
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sheppard, Mullin, Richter & Hampton LLP on behalf of Ap... FDA-2019-P-5571 · 7 docket documents Sheppard, Mullin, Richter & Hampton LLP filed this citizen petition on behalf of Apicore Pharmaceutical Private Ltd on November 25, 2019, requesting that the FDA require any ANDA or ANDA supplement for Penicillamine capsules be approved only if the bioequivalence study uses a bioanalytical method th | 505(q) | 2019-11-27 | Withdrawn | Apicore Pharmaceutical Private Ltd |
Citizen Petition from Sheppard, Mullin, Richter & Hampton LLP on behalf of Ap... FDA-2019-P-5463 · 7 docket documents Sheppard, Mullin, Richter & Hampton LLP, on behalf of Apicore Pharmaceutical Private, Ltd., filed this citizen petition requesting that the FDA require any Abbreviated New Drug Application or supplement for Penicillamine capsules be approved only if the bioequivalence study uses a bioanalytical meth | 505(q) | 2019-11-19 | Withdrawn | Apicore Pharmaceutical Private, Ltd. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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