POTASSIUM CHLORIDE | N019561 | KV PHARMACEUTICAL CO
| 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 |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-2181 Hyman, Phelps & McNamara, P.C. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Potassium Chloride Extended-release for Liquid Suspension in 8 mEq and 10 mEq strengths suitable for submission as an ANDA, with the | 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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