POTASSIUM CHLORIDE | N007865 | ELI LILLY AND CO
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - Micro-K LS -Orange Book: Approved Drug Products with Therapeut... FDA-2020-P-2181 · 6 docket documents 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 | Granted | Hyman, Phelps & McNamara, P.C. |
ATTACHMENT 3 HIGHLIGHTS OF PRESCRIBING INFORMATION POTASSIUM CHLORIDE extende... FDA-2020-P-2005 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding potassium chloride extended-release tablets, requesting FDA evaluation of the appropriateness of the product formulation and regulatory pathway for approval or continued marketing of this potassium supplementation medication. | Suitability | 2020-09-23 | Granted | HYMAN, PHELPS & MCNAMARA, P.C. |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2001-P-0412 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client 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, 15 mEq suitable for submission as an abbreviated new drug application b | Other | 2019-09-04 | Granted | Lachman Consultant Services, Inc. |
Citizen Petition from KV Pharmaceutical Company FDA-1996-P-0022 · 7 docket documents KV Pharmaceutical Company filed this citizen petition under Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting permission to file an Abbreviated New Drug Application for Potassium Chloride Extended-release Microparticle Packets in 10 mEq and 20 mEq strengths, which would have | Other | 2016-09-21 | Granted | KV Pharmaceutical Company |
Citizen Petition from NuTek Food Science LLC FDA-2016-P-1826 · 12 docket documents NuTek Food Science LLC filed this citizen petition under Section 401 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner issue guidance recognizing "potassium salt" as an additional common or usual name for potassium chloride as defined in 21 C.F.R. § 184.1622, to allow | Other | 2016-06-28 | Withdrawn | NuTek Food Science LLC |
Foley & Lardner LLP - Citizen Petition FDA-2008-P-0412 · 6 docket documents Foley & Lardner LLP filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and | 505(q) | 2008-07-18 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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