AMOXICILLIN | N050459 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Premier Consulting FDA-2024-P-3571 · 9 docket documents Premier Consulting filed this petition seeking permission to file an ANDA for Amoxicillin and Benazepril Hydrochloride Oral Liquid, and requesting that the FDA determine that "liquid" is an acceptable dosage form for these drugs under 21 CFR 314.94(a)(5). | Suitability | 2024-11-13 | Granted | Premier Consulting |
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 |
Aurobindo Pharmaceuticals Limited (EAS Consulting Group) - Citizen Petition FDA-2010-P-0177 · 5 docket documents Aurobindo Pharmaceuticals Limited, through EAS Consulting Group, filed this citizen petition on March 26, 2010, requesting that the FDA determine whether Augmentin ES-600 (amoxicillin; clavulanate potassium) 600/5mL, NDA 50-755, manufactured by SmithKline Beecham was withdrawn from sale for reasons | 505(q) | 2010-03-31 | Denied | — |
Aurobindo Pharmaceuticals, Ltd., (EAS Consulting Group, LLC) - Citizen Petition FDA-2010-P-0172 · 6 docket documents Aurobindo Pharmaceuticals Limited, represented by EAS Consulting Group LLC, filed this petition on March 23, 2010 requesting that the FDA determine whether GlaxoSmithKline's Augmentin (amoxicillin; clavulanate potassium) oral suspension 200mg/5mL and 400mg/5mL, NDA 50-725, was withdrawn from sale fo | 505(q) | 2010-03-29 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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