AMOXICILLIN; CLAVULANATE POTASSIUM | A065065 | CHARTWELL RX SCIENCES LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Schafer Veterinary Consultants, LLC FDA-2021-P-1245 · 5 docket documents Schafer Veterinary Consultants, LLC filed this suitability petition on November 19, 2021, requesting FDA approval under section 505(j)(2)(C) to submit an Abbreviated New Animal Drug Application (ANADA) for generic Amoxicillin and Clavulanate Potassium Chewable Tablets, which would include an additio | Suitability | 2021-11-22 | Open | Schafer Veterinary Consultants, LLC |
Attachment 5 Suitability Petition Approval Letter for Amoxicillin and Clavula... FDA-2016-P-3089 · 8 docket documents 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, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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