FDA — authorised 16 December 1965
- Marketing authorisation holder: HOSPIRA
- Status: approved
🇺🇸 Micro-K 10 in United States
FDA authorised Micro-K 10 on 16 December 1965
Marketing authorisations
FDA — authorised 16 December 1965
- Application: NDA013025
- Marketing authorisation holder: HOSPIRA
- Local brand name: THAM-E
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 February 1974
- Application: ANDA083345
- Marketing authorisation holder: HOSPIRA
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 1975
- Application: NDA017476
- Marketing authorisation holder: NOVARTIS
- Local brand name: SLOW-K
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 October 1977
- Application: ANDA085499
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 March 1978
- Application: ANDA085870
- Marketing authorisation holder: B BRAUN
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 February 1979
- Application: NDA017648
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 October 1980
- Application: NDA018238
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: MICRO-K 10
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 June 1981
- Application: ANDA087584
- Marketing authorisation holder: LUITPOLD
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 June 1981
- Application: ANDA087585
- Marketing authorisation holder: LUITPOLD
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 March 1982
- Application: ANDA086714
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 1982
- Application: ANDA086713
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 1982
- Application: NDA018722
- Marketing authorisation holder: B BRAUN
- Local brand name: SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 1984
- Application: NDA018494
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 January 1985
- Application: ANDA088901
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM CHLORIDE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 1985
- Application: ANDA088908
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM CHLORIDE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 April 1986
- Application: NDA019123
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: KLOR-CON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 February 1987
- Application: ANDA070980
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 September 1987
- Application: ANDA070618
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 October 1988
- Application: NDA019686
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 November 1992
- Application: NDA020161
- Marketing authorisation holder: OTSUKA ICU MEDCL
- Local brand name: POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 1993
- Application: ANDA070998
- Marketing authorisation holder: FUTURE PAK
- Local brand name: K+8
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 April 1996
- Application: ANDA073531
- Marketing authorisation holder: TEVA
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 April 1996
- Application: ANDA073532
- Marketing authorisation holder: TEVA
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 April 2002
- Application: ANDA076044
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 April 2002
- Application: ANDA075604
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 2 June 2008
- Application: ANDA077419
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 May 2011
- Application: ANDA200185
- Marketing authorisation holder: PADAGIS US
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 February 2013
- Application: ANDA202128
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 December 2013
- Application: ANDA202886
- Marketing authorisation holder: PH HEALTH
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 2014
- Application: NDA206814
- Marketing authorisation holder: GENUS LIFESCIENCES
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 August 2015
- Application: NDA208019
- Marketing authorisation holder: GENUS
- Local brand name: POTASSIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 5 November 2015
- Application: ANDA205993
- Marketing authorisation holder: PADAGIS US
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 January 2016
- Application: ANDA202868
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 January 2016
- Application: ANDA206347
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 July 2016
- Application: ANDA203562
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 August 2016
- Application: ANDA206759
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 August 2016
- Application: ANDA204828
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 August 2016
- Application: ANDA207528
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 October 2017
- Application: ANDA209662
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: KLOR-CON
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 12 January 2018
- Application: ANDA209688
- Marketing authorisation holder: TWI PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 June 2018
- Application: ANDA209314
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 July 2018
- Application: ANDA210041
- Marketing authorisation holder: AMNEAL
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 August 2018
- Application: ANDA211067
- Marketing authorisation holder: APOTEX
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 August 2018
- Application: ANDA209786
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 August 2018
- Application: ANDA210733
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 January 2019
- Application: ANDA206881
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 March 2019
- Application: ANDA210766
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA210098
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 May 2019
- Application: ANDA212183
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 11 June 2019
- Application: ANDA209026
- Marketing authorisation holder: PRINSTON INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 June 2019
- Application: ANDA210097
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 September 2019
- Application: ANDA212561
- Marketing authorisation holder: YICHANG HUMANWELL
- Status: approved
FDA — authorised 4 March 2020
- Application: ANDA211797
- Marketing authorisation holder: GRANULES
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 May 2020
- Application: ANDA212861
- Marketing authorisation holder: AMNEAL
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 August 2020
- Application: ANDA213588
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 September 2020
- Application: ANDA211087
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: POTASSIUM CHLORIDE 20MEQ
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 September 2020
- Application: ANDA210395
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 October 2020
- Application: ANDA214452
- Marketing authorisation holder: GRANULES
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 December 2020
- Application: ANDA214422
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 January 2021
- Application: ANDA214395
- Marketing authorisation holder: GUANGZHOU NOVAKEN
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 February 2021
- Application: ANDA214686
- Marketing authorisation holder: GRANULES
- Local brand name: POTASSIUM CHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 March 2021
- Application: ANDA211667
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 18 March 2021
- Application: ANDA214727
- Marketing authorisation holder: NEXUS
- Local brand name: POTASSIUM CHLORIDE 10MEQ
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 March 2021
- Application: ANDA214728
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 January 2022
- Application: ANDA214076
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 January 2022
- Application: ANDA213467
- Marketing authorisation holder: GRANULES
- Local brand name: POTASSIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 24 March 2022
- Application: ANDA214108
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA215370
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 25 July 2022
- Application: ANDA215725
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 November 2022
- Application: ANDA211665
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 December 2022
- Application: ANDA214892
- Marketing authorisation holder: ANDA REPOSITORY
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 March 2023
- Application: ANDA216156
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 12 July 2023
- Application: ANDA212816
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 14 August 2023
- Application: ANDA217704
- Marketing authorisation holder: NEXUS
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 2023
- Application: ANDA217412
- Marketing authorisation holder: RISING
- Local brand name: POTASSIUM CHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 April 2025
- Application: ANDA211992
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 10 September 2025
- Application: ANDA218733
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 27 October 2025
- Application: ANDA218979
- Marketing authorisation holder: TWI PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Micro-K 10, a generic version of a potassium chloride medication, for marketing in the United States. The approval was granted to TWI PHARMS on 27 October 2025, under the standard expedited pathway. The approval allows TWI PHARMS to market Micro-K 10 for the indication approved in the labelling.
FDA — authorised 20 November 2025
- Application: ANDA216536
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 December 2025
- Application: ANDA215716
- Marketing authorisation holder: QUAGEN
- Local brand name: POTASSIUM CHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA073398
- Marketing authorisation holder: SAVAGE LABS
- Local brand name: K-LEASE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087885
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088286
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA007865
- Marketing authorisation holder: LILLY
- Local brand name: POTASSIUM CHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA075775
- Marketing authorisation holder: ELAN PHARM
- Local brand name: POTASSIUM CHLORIDE
- Indication: Tablet, Extended Release — Oral
- Status: approved
Micro-K 10 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Micro-K 10 approved in United States?
Yes. FDA authorised it on 16 December 1965; FDA authorised it on 16 December 1965; FDA authorised it on 13 February 1974.
Who is the marketing authorisation holder for Micro-K 10 in United States?
HOSPIRA holds the US marketing authorisation.