POTASSIUM CHLORIDE | N018238 | NESHER PHARMACEUTICALS USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - Micro-K LS -Orange Book: Approved Drug Products with Therapeut... FDA-2020-P-2181 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Micro-K LS seeking to address its listing in the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), which classifies approved drugs and their therapeutic equivalence ratings for generic drug approval pu | Suitability | 2020-11-12 | Open | Hyman |
Attachment 2 - Micro-K Labeling RE Suitability Petition from Hyman, Phelps & ... FDA-2020-P-2181 Hyman, Phelps & McNamara, P.C. filed a petition regarding labeling suitability for Micro-K, a potassium chloride product. The petition requests that the FDA take action concerning the product's labeling to address suitability-related issues, though specific regulatory mechanisms and detailed request | Suitability | 2020-11-12 | Open | Hyman |
Attachment 3 - Proposed Micro-K LS Labeling RE Suitability Petition from Hyma... FDA-2020-P-2181 I cannot locate specific details about the filing party, the drug product, or the requested regulatory action in the text provided. The document title references Micro-K LS and a suitability petition, but does not include the substantive petition content that would contain information about who file | Suitability | 2020-11-12 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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