Viewing data from:

POTASSIUM CHLORIDE

ANDA

POTASSIUM CHLORIDE | A211067 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

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 16, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 20MEQ/15ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Aug 8, 2018

No patent or exclusivity listings for this strength.

#002 — 40MEQ/15ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Aug 8, 2018

Change History (4)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Apotex's potassium chloride NDA 211067 changed from prescription (RX) to discontinued (DISCN) status.

Old: RX

New: DISCN

MODIFIEDtype7/1/2026

Apotex's potassium chloride product (NDA 211067, supplement 002) transitioned from prescription status to discontinued.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Apotex's potassium chloride product (NDA 211067, supplement 002) had its therapeutic equivalence code changed from AA.

Old: AA

MODIFIEDTE Code7/1/2026

Apotex's potassium chloride (NDA 211067) had its therapeutic equivalence code changed from AA to a different designation.

Old: AA