CEFIXIME | A065380 | LUPIN LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aleon Pharma International, Inc. (Zhuhai Kinhoo Pharmac... FDA-2016-P-3510 Aleon Pharma International, Inc., on behalf of Zhuhai Kinhoo Pharmaceutical Co., Ltd, filed this citizen petition pursuant to Section 505(j)(2)(C) requesting FDA approval of a suitability petition to allow submission of an abbreviated new drug application for Cefadroxil Chewable Tablets in 125 mg an | Other | 2016-10-25 | Open | Aleon Pharma International |
Citizen Petition from Aleon Pharma International, Inc FDA-2016-P-3089 Aleon Pharma International, Inc. filed this citizen petition on September 30, 2016, pursuant to Section 505(j)(2)(C) requesting that the FDA declare cefixime tablets for oral suspension in strengths of 50 mg, 100 mg, and 200 mg suitable for submission in an abbreviated new drug application, with the | Other | 2016-10-04 | Open | Aleon Pharma International |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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