AMOXICILLIN | N050460 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 5 Suitability Petition Approval Letter for Amoxicillin and Clavula... FDA-2016-P-3089 Aleon Pharma International, Inc. filed a citizen petition requesting FDA approval of a suitability petition for amoxicillin and clavulanate potassium tablets, which the agency approved. The petition sought regulatory confirmation that the proposed formulation and manufacturing process for this combi | Suitability | 2016-10-04 | Open | Aleon Pharma International |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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