POTASSIUM CHLORIDE | N019561 | KV PHARMACEUTICAL CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-2181 · 6 docket documents 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 | Granted | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-0438 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition under 21 C.F.R. §§ 10.25 and 10.30 and pursuant to Sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether Micro-KO LS Packets (potassium chloride) 20 mEq Extended-release Liquid Suspension, approved under NDA num | 505(q) | 2020-01-27 | Granted | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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