POTASSIUM CHLORIDE | N018279 | ABBVIE INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Granules India Limited FDA-2023-P-2339 Granules India Limited filed this citizen petition under 21 CFR 10.25, 10.30, and sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether K-TAB (Potassium Chloride) Extended Release Tablets 10 mEq and 20 mEq, NDA No. 018279, held by ABBVIE INC, was withdrawn for safety or | 505(q) | 2023-06-08 | Granted | Granules India Limited |
ATTACHMENT 2 HIGHLIGHTS OF PRESCRIBING INFORMATION K-TAB (potassium chloride)... FDA-2020-P-2005 The law firm Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding K-TAB (potassium chloride) extended-release tablets. The petition requested FDA evaluation of the suitability of this product, though the specific regulatory action sought is not detailed in the provided text excerpt. | Suitability | 2020-09-23 | Granted | HYMAN, PHELPS & MCNAMARA, P.C. |
Suitability Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-2005 The law firm Hyman, Phelps & McNamara filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Potassium Chloride Extended-release Tablets, 15 mEq, suitable for submission as an Abbreviated New Drug Application, with K-TAB (po | Suitability | 2020-09-23 | Granted | HYMAN, PHELPS & MCNAMARA, P.C. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2018-P-0870 Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Potassium Chloride Extended Release Tablets, 8 mEq, suitable for submission as an abbreviated new drug application (ANDA), with th | Other | 2018-02-26 | Denied | Lachman Consultant Services, Inc. |
Citizens Petition Approval letter to Robert Dormer and Gordon Johnston FDA-2014-P-1657 Robert Dormer and Gordon Johnston filed citizen petitions requesting that the FDA designate K-Tab (potassium chloride extended-release tablets, USP), 20 mEq, approved under NDA 18279 and marketed by Abbvie, as a reference listed drug in the Orange Book to enable submission of abbreviated new drug ap | 505(q) | 2014-11-13 | Granted | — |
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2014-P-1657 Gordon Johnston Regulatory Consultants LLC filed this citizen petition on October 17, 2014, requesting that the FDA designate K-Tab potassium chloride extended-release tablets 20 mEq (Abbvie Inc., NDA 18279) as a second reference listed drug in the Orange Book to enable ANDA submissions by other spo | Other | 2014-10-20 | Granted | Gordon Johnston Regulatory Consultants LLC |
Citizen Petition From Hyman, Phelps & McNamara , P.C. FDA-2014-P-0328 Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that FDA designate K-Tab (potassium chloride extended release tablets, USP, 20 meq., NDA No. 18279) as a Reference Listed Drug in the Orange Book to allow generic applicants to submit ANDAs referencing this product, since the curr | 505(q) | 2014-03-28 | Granted | Hyman, Phelps & McNamara , P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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