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MICRO-K LS

NDA

POTASSIUM CHLORIDE | N019561 | KV PHARMACEUTICAL CO

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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	Granted	Hyman, Phelps & McNamara, P.C.
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	Granted	Hyman, Phelps & McNamara, P.C.
Attachment 3 - Proposed Micro-K LS Labeling RE Suitability Petition from Hyma... FDA-2020-P-2181	Suitability	2020-11-12	Granted	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-0438 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.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain13 active DMFs6 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

KLINGE CHEMICALS LTDPOTASSIUM CHLORIDE USP

DMF 39531980

AURORIUM LLCPOTASSIUM CHLORIDE

DMF 54401984

DEAD SEA WORKS LTDPOTASSIUM CHLORIDE

DMF 165352003

K+S MINERALS AND AGRICULTURE GMBHPOTASSIUM CHLORIDE 99.9% KCI PH. EUR., USP

DMF 255952012

NANDU CHEMICAL INDUSTRIESPOTASSIUM CHLORIDE BP

DMF 258402011

ALIVUS LIFE SCIENCES LTDPOTASSIUM CHLORIDE USP

DMF 286512014

VM CHEMICALSPOTASSIUM CHLORIDE BP

DMF 290402015

MACCO ORGANIQUES SROPOTASSIUM CHLORIDE

DMF 318512017

GLOBAL CALCIUM PRIVATE LTDPOTASSIUM CHLORIDE USP

DMF 368742023

THINQ PHARMA-CRO LTDPOTASSIUM CHLORIDE USP

DMF 385732023

MAITHRI DRUGS PRIVATE LTDPOTASSIUM CHLORIDE USP

DMF 401392024

EMNAR PHARMA PRIVATE LTDPOTASSIUM CHLORIDE

DMF 409112024

MUBY CHEM PRIVATE LTDPOTASSIUM CHLORIDE USP

DMF 411312025

KV PHARMACEUTICAL COInactivePOTASSIUM CHLORIDE SUSTAINED RELEASE CAPSULES 600MG

DMF 28181977

HEICO CHEMICALS DIV WHITTAKER CORPInactivePOTASSIUM CHLORIDE

DMF 52211983

KALI UND SALZ AGInactivePOTASSIUM CHLORIDE USP PRODUCED IN THE HERINGEN (GERMANY) PLANT.

DMF 55481984

MALLINCKRODT CHEMICAL INCInactivePOTASSIUM CHLORIDE

DMF 80191989

EURAND AMERICA INCInactivePOTASSIUM CHLORIDE MICROCAPS COMPRESSIBLE

DMF 89961991

WUHAN SHIJI PHARMACEUTICAL CO LTDInactivePOTASSIUM CHLORIDE

DMF 206162007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 24, 2005	SUPPL -4	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SUSPENSION, EXTENDED RELEASE;ORAL | Approved: Aug 26, 1988

No patent or exclusivity listings for this strength.