AZITHROMYCIN | N050730 | PFIZER CENTRAL RESEARCH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lupin Pharmaceuticals, Inc FDA-2018-P-2862 Lupin Pharmaceuticals, Inc. filed this citizen petition on July 23, 2018, pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 10.25(a) and 10.30, requesting that the FDA designate a suitable alternate Reference Standard for Azithromycin Tablet, 600 mg because the curren | Other | 2018-07-24 | Denied | Lupin Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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