TACROLIMUS | A206651 | AJENAT PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Belcher Pharmaceuticals, LLC FDA-2020-P-1247 Belcher Pharmaceuticals, LLC filed this citizen petition pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require current holders of abbreviated new drug applications for tacrolimus oral capsule products approved before December 2012 to demonstrate bioeq | 505(q) | 2020-04-03 | Denied | Belcher Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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