potassium chloride
Trade name: klor-con
Approved
Dec 7, 1953
Potassium is needed to maintain good health. When potassium level falls below 3.5 mmol/L, Hypokalemia is diagnosed. In case of extremely low level of potassium (lower than 2.5 mmol/L) the following symptoms are appeared: malaise and fatigue. This low level of potassium can lead to severe muscle weakness and paralysis; respiratory failure; intermittent muscle spasms. It is known, foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke. Potassium supplementation is also recommended as an adjuvant antihypertensive agent for patients with essential hypertension. — NCATS
Clinical trial activity
85 trials · 97 clinical orgs · 106 marketing orgs
Earliest trial started Jul 1, 2002 (NCT00224939)
Timeline
1950s
- Dec 7, 1953
Earliest FDA Approval
- Dec 7, 1953
DAVA Pharmaceuticals — Marketing Organization
1970s
- Mar 22, 1971
Baxalta — NDA Secondary Org
- Mar 22, 1971
Baxter — NDA Secondary Org
- May 25, 1971
Baxter — Marketing Organization
- Jun 30, 1971
Fresenius — Marketing Organization
- Sep 24, 1971
B. Braun — Marketing Organization
- Sep 24, 1971
B. Braun — NDA Secondary Org
- Apr 25, 1975
Novartis — NDA Secondary Org
- Aug 13, 1975
ICU Medical Inc — NDA Secondary Org
- Aug 29, 1975
International Medication — Marketing Organization
- Sep 5, 1979
Bristol-Myers — Marketing Organization
1980s
- May 22, 1980
Apothecon — NDA Secondary Org
- Jun 9, 1980
AbbVie — NDA Secondary Org
- Oct 17, 1980
Nesher Pharms — NDA Secondary Org
- Jun 30, 1981
Lutipold — Marketing Organization
- Oct 28, 1981
Alcon — Marketing Organization
- Oct 28, 1981
Nestle — NDA Secondary Org
- Mar 16, 1982
Abraxis — Marketing Organization
- Aug 12, 1982
G D Searle — Marketing Organization
- Jul 13, 1984
Braintree Laboratories — Marketing Organization
- Jul 13, 1984
Braintree Laboratories — NDA Secondary Org
- Oct 26, 1984
Mylan — NDA Secondary Org
- Apr 17, 1986
Upsher-Smith Laboratories — First NDA Organization
- Apr 17, 1986
Upsher-Smith Laboratories — NDA Organization
- Apr 17, 1986
Upsher-Smith Laboratories — NDA Secondary Org
- May 9, 1986
Norbrook — Marketing Organization
- Jun 13, 1986
Schering — NDA Secondary Org
- Jun 13, 1986
Schering-Plough — NDA Secondary Org
- Sep 16, 1986
West-Ward Pharmaceutical — Marketing Organization
- Dec 16, 1986
Abbott — Marketing Organization
- Dec 16, 1986
Abbott — NDA Secondary Org
- Feb 17, 1987
Nesher Pharms — Marketing Organization
- Sep 9, 1987
Copley Pharmaceuticals — Marketing Organization
- Oct 22, 1987
Future Pak — Marketing Organization
- Apr 20, 1988
Dynapharm — Marketing Organization
- Aug 26, 1988
Lumara Health — NDA Secondary Org
- Dec 23, 1988
Goldline — Marketing Organization
- Apr 14, 1989
Bristol-Myers Squibb — Marketing Organization
1990s
- Oct 15, 1990
Barr Laboratories — Marketing Organization
- Aug 23, 1991
Pharmacia & Upjohn — Marketing Organization
- Nov 27, 1991
Akorn, Inc. — Marketing Organization
- Nov 27, 1991
Akorn, Inc. — NDA Secondary Org
- Jan 28, 1992
Vintage — Marketing Organization
- Aug 1, 1994
Hikma — Marketing Organization
- Apr 26, 1996
Teva — Marketing Organization
- Sep 27, 1996
Lukare Medical — Marketing Organization
- Sep 27, 1996
Lukare Medical — NDA Secondary Org
- Nov 20, 1998
Upsher-Smith Laboratories — Marketing Organization
- May 11, 1999
Lederle — Marketing Organization
- May 11, 1999
American Home Products — Marketing Organization
- Jun 17, 1999
Duramed Research — Marketing Organization
2000s
- Jun 28, 2001
Elan Pharmaceuticals — Marketing Organization
- Apr 10, 2002
Actavis — Marketing Organization
- Aug 18, 2004
Adare Pharmaceuticals — Marketing Organization
- Jan 1, 2005
Earliest Phase 3 Sponsor(trial)
- Aug 2, 2006
Salix — Marketing Organization
- Aug 2, 2006
Salix — NDA Secondary Org
- Oct 25, 2006
Baxalta — Marketing Organization
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
- Apr 30, 2007
Accord Research — Marketing Organization
- Sep 10, 2008
ICU Medical Inc — Marketing Organization
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
- Mar 31, 2009
Sandoz — Marketing Organization
- May 27, 2009
Novel Anti-Infective Technologies, LLC — Marketing Organization
2010s
- Jan 8, 2010
Pharmachemie Bv — Marketing Organization
- Jan 28, 2010
Mylan — Marketing Organization
- Feb 25, 2010
Paddock Laboratories — Marketing Organization
- Feb 25, 2010
Perrigo — Marketing Organization
- May 18, 2011
Padagis Us — Marketing Organization
- Feb 22, 2013
Amneal Pharmaceuticals — Marketing Organization
- Dec 26, 2013
Anchen Pharmaceuticals, Inc — Marketing Organization
- Dec 26, 2013
Par Pharmaceuticals — Marketing Organization
- Aug 25, 2014
Fresenius — NDA Secondary Org
- Dec 22, 2014
Genus Oncology, LLC — NDA Secondary Org
- Apr 13, 2015
Strides Pharma Science — Marketing Organization
- May 21, 2015
Sun Pharmaceuticals — Marketing Organization
- Aug 19, 2015
Pharmaceutical Research Associates, Inc. (PRA) — NDA Secondary Org
- Dec 8, 2015
ANDA Repository — Marketing Organization
- Dec 8, 2015
Pharmaceutics International, Inc. — Marketing Organization
- Dec 18, 2015
Lupin — Marketing Organization
- Jan 19, 2016
Glenmark Pharmaceuticals — Marketing Organization
- Mar 4, 2016
Tris Pharma, Inc. — Marketing Organization
- Mar 28, 2016
Lannett Company, Inc. — Marketing Organization
- Mar 28, 2016
Chartwell Pharmaceuticals — Marketing Organization
- Aug 19, 2016
Sigmapharm Laboratories — Marketing Organization
- Mar 8, 2017
Esteve Labs — Marketing Organization
- Mar 8, 2017
Nostrum Laboratories — Marketing Organization
- Apr 25, 2017
Azurity — Marketing Organization
- Apr 25, 2017
Silvergate Pharmaceuticals — Marketing Organization
- Jan 12, 2018
Vitruvias Therapeutics — Marketing Organization
- Jan 12, 2018
TWi Biotechnology, Inc. — Marketing Organization
- May 4, 2018
Bausch Health Companies — NDA Secondary Org
- Jun 22, 2018
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
- Aug 8, 2018
Apotex — Marketing Organization
- Aug 9, 2018
Sagent Pharmaceuticals, Inc. — Marketing Organization
- Nov 23, 2018
Epic Pharma Llc — Marketing Organization
- Dec 19, 2018
Aurobindo Pharma — Marketing Organization
- Mar 11, 2019
Zydus Discovery DMCC — Marketing Organization
- Mar 29, 2019
Pharmaceutical Associates — Marketing Organization
- Apr 30, 2019
Prinston Inc — Marketing Organization
- May 6, 2019
Belcher Pharmaceuticals — Marketing Organization
2020s
- Jan 30, 2020
Eugia Pharma — Marketing Organization
- Mar 4, 2020
Granules India — Marketing Organization
- Aug 21, 2020
Centaur Pharmaceuticals — Marketing Organization
- Aug 21, 2020
Unichem — Marketing Organization
- Dec 29, 2020
Ascent Pharmahealth — Marketing Organization
- Dec 29, 2020
AbbVie — Marketing Organization
- Jan 28, 2021
Amta — Marketing Organization
- Jan 28, 2021
GUANGZHOU NOVAKEN — Marketing Organization
- Mar 18, 2021
Nexus Pharmaceuticals — Marketing Organization
- Apr 23, 2021
Lotus Pharmaceutical — Marketing Organization
- May 21, 2021
Saptalis Pharmaceuticals — Marketing Organization
- Jan 13, 2022
Rubicon Research — Marketing Organization
- Jun 6, 2022
Wes Pharma Inc — Marketing Organization
- Dec 30, 2022
Guardian Drug — Marketing Organization
- Jul 12, 2023
Ani Pharmaceuticals — Marketing Organization
- Aug 7, 2023
Daito Pharmaceuticals — Marketing Organization
- Dec 19, 2023
Rising Pharmaceuticals — Marketing Organization
Indications
Approved for
Studied for
- Acidosis · Phase 2
- Acute Coronary Syndrome · Phase 2
- Acute Kidney Injury · Phase 4
- Air Travel · Phase 2/Phase 3
- Alcoholic Intoxication · Phase 4
- Anesthesia · Phase 3
- Aortic Valve Disease · Phase 4
- Aortic Valve Stenosis · Phase 2
- Arrhythmias, Cardiac · Phase 4
- Atrial Fibrillation · Phase 4
- Atrial Flutter · Phase 4
- Behcet Syndrome · Phase 4
- Blood Loss, Surgical · Phase 4
- Blood Pressure · Phase 4
- Body Fluids · Phase 4
- Bone Diseases · Phase 2
- Brain Neoplasms · Phase 2
- Burns · Phase 4
- Cardiovascular Diseases · Phase 3
- Cataract · Phase 2
- Cathartics · Phase 4
- Colonic Polyps · Phase 4
- Colonoscopy · Phase 4
- Colorectal Surgery · Phase 4
- Conjunctivitis, Bacterial · Phase 4
- Critical Illness · Phase 4
- Dehydration · Phase 4
- Diabetic Ketoacidosis · Phase 3
- Diabetic Retinopathy · Phase 2
- Emergencies · Phase 4
- Endocarditis · Phase 4
- Epiretinal Membrane · Phase 4
- General Surgery · Phase 4
- Glaucoma · Phase 2/Phase 3
- Glaucoma, Neovascular · Phase 2
- Glaucoma, Open-Angle · Phase 2
- Heart Diseases · Phase 3
- Heart Failure · Phase 2
- Heart Failure, Diastolic · Phase 2
- Heart Septal Defects, Atrial · Phase 3
- Heart Septal Defects, Ventricular · Phase 3
- Hyperlactatemia · Early Phase 1
- Hypernatremia · Phase 4
- Hypertension · Phase 4
- Hypertrophy, Left Ventricular · Phase 3
- Hypokalemia · Phase 4
- Hyponatremia · Phase 4
- Hypotension · Phase 4
- Hypovolemia · Phase 4
- Inflammation · Phase 4
- Intubation · Phase 3
- Kidney Diseases · Phase 4
- Kidney Transplantation · Phase 2
- Liver Transplantation · Phase 4
- Metabolic Syndrome · Phase 4
- Metabolism · Phase 2
- Mitral Valve · Phase 4
- Obesity · Phase 4
- Pancreatic Neoplasms · Phase 4
- Peritonitis · Phase 4
- Pharmacology · Phase 2
- Plasma · Phase 4
- Pneumonia · Phase 4
- Prehypertension · Phase 1/Phase 2
- Respiratory Insufficiency · Phase 3
- Sepsis · Phase 4
- Subarachnoid Hemorrhage · Phase 1
- Thoracic Surgery · Phase 4
- Tissue Adhesions · Phase 2
- Traumatology · Phase 3
- Zika Virus · Phase 1
Mechanism of action
- ElectrolyteSupplementation
Electrolyte supplementation
Combination products
acetated ringer's
aminosyn ii m in dextrose
with amino acids, sodium phosphate, sodium chloride, glucose monohydrate, magnesium
aminosyn ii w/ elect and adjusted phosphate in dextrose
with amino acids, potassium acetate, sodium chloride, potassium phosphate, glucose monohydrate, magnesium
aminosyn ii w/ electrolytes
with amino acids, sodium chloride, potassium phosphate, magnesium
aminosyn ii w/ electrolytes in dextrose
with amino acids, sodium chloride, potassium phosphate, glucose monohydrate, magnesium
aminosyn ii w/ electrolytes in dextrose w/ calcium
with amino acids, sodium chloride, calcium chloride, potassium phosphate, glucose monohydrate, magnesium
aminosyn w/electrolytes
with amino acids, sodium phosphate, sodium chloride, magnesium
Also known as aminosyn ii m, aminosyn ii w/electrolytes
bss plus
with sodium bicarbonate, sodium phosphate, sodium chloride, calcium chloride, glucose monohydrate, glutathione, magnesium
Also known as methotrexate sodium
dextrose and electrolyte
with lactic acid, sodium chloride, potassium phosphate, glucose monohydrate, magnesium
dextrose in acetated ringer's
with sodium acetate, sodium chloride, calcium chloride, glucose monohydrate
dextrose in ringer's
with sodium chloride, calcium chloride, glucose monohydrate
Also known as dextrose and ringer's
elliotts b solution
with magnesium sulfate, sodium bicarbonate, sodium phosphate, sodium chloride, calcium chloride, glucose monohydrate
freamine iii w/ electrolytes
with phosphoric acid, sodium acetate, amino acids, sodium chloride, magnesium
golytely
with sodium sulfate, sodium bicarbonate, sodium chloride, polyethylene glycol
Also known as clenz-lyte, co-lav, colovage, colyte, colyte-flavore, colyte with flavor packs, glycoprep, go-evac, ocl, peg 3350 and electrolytes, polyethylene glycol 3350 and electrolytes
halflytely
with bisacodyl, sodium bicarbonate, sodium chloride, polyethylene glycol
Also known as peg-3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl
ionosol b and dextrose
with lactic acid, sodium phosphate, sodium chloride, potassium phosphate, glucose monohydrate, magnesium
ionosol mb and dextrose
with lactic acid, sodium phosphate, potassium phosphate, glucose monohydrate, magnesium
ionosol t and dextrose
with sodium phosphate, potassium lactate, sodium chloride, glucose monohydrate
isolyte e
with sodium citrate, sodium acetate, sodium chloride, calcium chloride, magnesium
Also known as balanced salt, bss
isolyte e w/ dextrose
with sodium citrate, sodium acetate, sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as isolyte e in dextrose
isolyte h w/ dextrose
with sodium acetate, sodium chloride, glucose monohydrate, magnesium
Also known as isolyte h in dextrose
isolyte m w/ dextrose
with sodium acetate, sodium chloride, potassium phosphate, glucose monohydrate
Also known as isolyte m in dextrose
isolyte p w/ dextrose
with sodium acetate, potassium phosphate, glucose monohydrate, magnesium
Also known as isolyte p in dextrose
isolyte r w/ dextrose
with sodium acetate, sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as isolyte r in dextrose
isolyte s ph
with sodium acetate, sodium phosphate, sodium chloride, potassium phosphate, sodium gluconate, magnesium
kabiven
with soybean oil, magnesium sulfate, sodium acetate, amino acids, sodium glycerophosphate pentahydrate, calcium chloride, glucose monohydrate
Also known as perikabiven
lactated ringer's
lactated ringer's and dextrose
with lactic acid, sodium chloride, calcium chloride, glucose monohydrate
Also known as dextrose and lactated ringer's, dextrose in half-strength lactated ringer's, dextrose in lactated ringer's, dextrose in modified lactated ringer's, potassium chloride in dextrose and lactated ringer's
moviprep
with vitamin c, sodium sulfate, sodium chloride, polyethylene glycol
Also known as peg-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic aci, plenvu
navstel
with sodium bicarbonate, sodium phosphate, sodium chloride, oxiglutatione, calcium chloride, glucose monohydrate, magnesium
normosol-r
with sodium acetate, sodium chloride, sodium gluconate, magnesium
Also known as isolyte s, physiolyte, physiosol, physiosol ph, plasma-lyte a
normosol-r and dextrose
with sodium acetate, sodium chloride, glucose monohydrate, sodium gluconate, magnesium
Also known as isolyte s in dextrose, isolyte s w/ dextrose, plasma-lyte 148 and dextrose
nulytely-flavore
with sodium bicarbonate, sodium chloride, polyethylene glycol
Also known as lax-lyte with flavor packs, nulytely, peg-3350, potassium chloride, sodium bicarbonate, sodium chloride, trilyte
phoxillum bk
with sodium bicarbonate, sodium phosphate, sodium chloride, calcium chloride, magnesium
Also known as phoxillum b22k
plasma-lyte m and dextrose
with sodium acetate, lactic acid, sodium chloride, calcium chloride, glucose monohydrate, magnesium
plasma-lyte r
with sodium acetate, lactic acid, sodium chloride, calcium chloride, magnesium
plegisol
with sodium chloride, calcium chloride, magnesium
Also known as cardioplegic
prismasol bk
with lactic acid, sodium bicarbonate, sodium chloride, calcium chloride, glucose monohydrate, magnesium
Also known as prismasol b22gk, prismasol bgk
procalamine
with glycerin, calcium, phosphoric acid, sodium acetate, amino acids, sodium chloride, magnesium
ringer's
suclear
with magnesium sulfate, potassium sulfate, sodium sulfate, sodium bicarbonate, sodium chloride, polyethylene glycol
suflave
with magnesium sulfate, sodium sulfate, sodium chloride, polyethylene glycol
sutab
tham-e
with tromethamine, sodium chloride
tis-u-sol
with magnesium sulfate, sodium phosphate, sodium chloride, potassium phosphate
tpn electrolytes
with sodium acetate, sodium chloride, calcium chloride, magnesium
veinamine
with sodium acetate, amino acids, potassium acetate, magnesium
Approval history
- approvedPriority reviewDec 7, 1953
Chemistry & pharmacology
SMILES
[K+]- Mol. weight
- 39.0983 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- Yes
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaPotassium chloride ↗
- NCATS295O53K152 ↗
- ChEMBLCHEMBL2105669 ↗
- ChEMBLCHEMBL1257051 ↗
- ChEMBLCHEMBL1200731 ↗
Also known as
- chlorid draselny
- chlorid draselny
- chloride of potash
- chloride of potash
- diffu-k
- diffu-k
- duro-k
- e508
- e508
- k+10
- k+10
- kaleorid
- kaleorid
- kaleorid lp
- kaliumchlorid
- kaliumchlorid
- kaon cl
- kaon cl
- kaon-cl
- kaon-cl
- kaon cl-10
- kaon cl-10
- kato
- kato
- kay-cee-l
- kay-cee-l
- kcl
- kcl
- [kcl]
- [kcl]
- k-contin
- k-contin
- k-dur
- k-dur
- k-dur 20
- k-lease
- k-lease
- klor-con
- klor-con
- klor-con 10
- klor-con 10
- klor-con 10meq
- klor-con 8
- klor-con m10
- klor-con m10
- klor-con m15
- klor-con m15
- klor-con m20
- klor-con m20
- kloref
- kloref-s
- klotrix
- klotrix
- k-tab
- k-tab
- leo k
- leo k
- micro k
- micro k
- micro-k
- micro-k
- micro-k 10
- micro-k 10
- micro-k ls
- micro-k ls
- monopotassium chloride
- monopotassium chloride
- muriate of potash
- muriate of potash
- nu-k
- nu-k
- plasmalyte a
- plasmalyte a
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- potassium chloride
- pot chlor (pot 12mmol)
- pot chlor strong
- sando-k
- sando-k
- slow-k
- slow-k
- sylvite
- sylvite
- ten-k
- ten-k
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07294807 | N/A | Dec 25, 2025 | Peking University |
| NCT07085806 | N/A | Jan 1, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06805487 | Phase 1 | Sep 24, 2024 | Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT06080178 | Phase 4 | Oct 1, 2023 | Algemeen Ziekenhuis Maria Middelares |
| NCT06076330 | N/A | Sep 30, 2023 | Institute of Liver and Biliary Sciences, India |
| NCT05752279 | Phase 3 | Apr 30, 2023 | University of New South Wales |
| NCT05758142 | N/A | Mar 29, 2023 | National Institute of General Medical Sciences (NIGMS), Tulane University |
| NCT05591612 | N/A | Nov 1, 2022 | American Society for Nutrition, Texas Tech University |
| NCT05355974 | Phase 3 | Aug 9, 2022 | Wright State University |
| NCT05253209 | Phase 3 | Jun 29, 2022 | Asklepion, Indiana University |
| NCT05398679 | Phase 4 | Jun 1, 2022 | University of Barcelona |
| NCT05138575 | Phase 2 | Nov 30, 2021 | University of Pennsylvania |
| NCT04913805 | Phase 2 | Oct 11, 2021 | University of Pennsylvania |
| NCT04802785 | Phase 2/Phase 3 (Phase 3) | Jun 30, 2021 | lurye Clinic |
| NCT04519164 | Phase 4 | Dec 1, 2020 | Harvard University |
| NCT04474002 | Phase 4 | Aug 31, 2020 | The University of Hong Kong |
| NCT04316611 | Phase 2 | Apr 30, 2020 | Assistance Publique - Hôpitaux de Paris |
| NCT04184401 | Phase 4 | Jan 1, 2020 | Green Cross Corporation, Seoul National University |
| NCT04758156 | Phase 4 | Aug 1, 2019 | Seoul National University |
| NCT03992365 | Phase 3 | Jun 10, 2019 | China Medical University, Universal Integrated Corp. |
Organizations
Research & Development (97)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| The University of Texas, Dallas | Academic/Hospital | 5 | 4 | 3 | 2007 |
| University of Pennsylvania | Academic/Hospital | 5 | 5 | 1 | 2015 |
| B. Braun | For profit | 4 | 4 | 1 | 2010 |
| Yuria-Pharm | For profit | 4 | 4 | 1 | 2016 |
| Alcon | For profit | 3 | 2 | 2 | 2008 |
| Fresenius | For profit | 3 | 0 | 1 | 2011 |
| Allegro Ophthalmics, LLC | For profit | 2 | 2 | 1 | 2014 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 2 | 2 | 2 | 2018 |
| Duke University | Academic/Hospital | 2 | 1 | 1 | 2014 |
| European Society of Anaesthesiology | Academic/Hospital | 2 | 0 | 1 | 2017 |
| Institute of Liver and Biliary Sciences, India | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Maastricht University | Academic/Hospital | 2 | 0 | 1 | 2017 |
| Seoul National University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Texas A&M University | Academic/Hospital | 2 | 2 | 1 | 2004 |
| Thomas Jefferson University | Academic/Hospital | 2 | 2 | 1 | 2009 |
| University of Barcelona | Academic/Hospital | 2 | 2 | 1 | 2018 |
| University of Colorado, Denver | Academic/Hospital | 2 | 1 | 2 | 2014 |
| University of Sao Paulo | Academic/Hospital | 2 | 2 | 1 | 2008 |
| Washington University in St. Louis | Academic/Hospital | 2 | 2 | 2 | 2015 |
| Aalborg University | Academic/Hospital | 1 | 1 | 1 | 2014 |
Marketing (148)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Dec 8, 2015 |
| AbbVie | For profit | NDA2 | Jun 9, 1980 |
| AbbVie | For profit | MKTG | Dec 29, 2020 |
| Abbott | For profit | MKTG | Dec 16, 1986 |
| Abbott | For profit | NDA2 | Dec 16, 1986 |
| Abraxis | For profit | MKTG | Mar 16, 1982 |
| Accord Research | For profit | MKTG | Apr 30, 2007 |
| Actavis | For profit | MKTG | Apr 10, 2002 |
| Adare Pharmaceuticals | For profit | MKTG | Aug 18, 2004 |
| Akorn, Inc. | For profit | MKTG | Nov 27, 1991 |
| Akorn, Inc. | For profit | NDA2 | Nov 27, 1991 |
| Alcon | For profit | MKTG | Oct 28, 1981 |
| Alcon | For profit | SYN | Jul 24, 2008 |
| American Home Products | For profit | MKTG | May 11, 1999 |
| Amneal Pharmaceuticals | For profit | SYN | May 8, 2020 |
| Amneal Pharmaceuticals | For profit | MKTG | Feb 22, 2013 |
| Amneal Pharmaceuticals | For profit | SYN | Jul 19, 2018 |
| Amta | For profit | MKTG | Jan 28, 2021 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Dec 26, 2013 |
| Ani Pharmaceuticals | For profit | MKTG | Jul 12, 2023 |
| Apotex | For profit | SYN | Aug 8, 2018 |
| Apotex | For profit | MKTG | Aug 8, 2018 |
| Apothecon | For profit | NDA2 | May 22, 1980 |
| Ascent Pharmahealth | For profit | MKTG | Dec 29, 2020 |
| Aurobindo Pharma | For profit | SYN | Feb 5, 2004 |
| Aurobindo Pharma | For profit | SYN | Dec 19, 2018 |
| Aurobindo Pharma | For profit | MKTG | Dec 19, 2018 |
| Azurity | For profit | MKTG | Apr 25, 2017 |
| B. Braun | For profit | MKTG | Sep 24, 1971 |
| B. Braun | For profit | NDA2 | Sep 24, 1971 |
| Barr Laboratories | For profit | MKTG | Oct 15, 1990 |
| Bausch Health Companies | For profit | NDA2 | May 4, 2018 |
| Baxalta | For profit | MKTG | Oct 25, 2006 |
| Baxalta | For profit | NDA2 | Mar 22, 1971 |
| Baxter | For profit | NDA2 | Mar 22, 1971 |
| Baxter | For profit | MKTG | May 25, 1971 |
| Belcher Pharmaceuticals | For profit | SYN | May 6, 2019 |
| Belcher Pharmaceuticals | For profit | MKTG | May 6, 2019 |
| Braintree Laboratories | For profit | MKTG | Jul 13, 1984 |
| Braintree Laboratories | For profit | SYN | Jan 18, 2013 |
| Braintree Laboratories | For profit | NDA2 | Jul 13, 1984 |
| Bristol-Myers | For profit | MKTG | Sep 5, 1979 |
| Bristol-Myers Squibb | For profit | MKTG | Apr 14, 1989 |
| Bristol-Myers Squibb | For profit | SYN | Feb 14, 1985 |
| Centaur Pharmaceuticals | For profit | MKTG | Aug 21, 2020 |
| Chartwell Pharmaceuticals | For profit | MKTG | Mar 28, 2016 |
| Chartwell Pharmaceuticals | For profit | SYN | Apr 26, 2019 |
| Copley Pharmaceuticals | For profit | MKTG | Sep 9, 1987 |
| DAVA Pharmaceuticals | For profit | MKTG | Dec 7, 1953 |
| Daito Pharmaceuticals | For profit | MKTG | Aug 7, 2023 |
| Duramed Research | For profit | MKTG | Jun 17, 1999 |
| Dynapharm | For profit | MKTG | Apr 20, 1988 |
| E Z EM | For profit | MKTG | — |
| Elan Pharmaceuticals | For profit | MKTG | Jun 28, 2001 |
| Eli Lilly | For profit | NDA2 | — |
| Epic Pharma Llc | For profit | MKTG | Nov 23, 2018 |
| Esteve Labs | For profit | MKTG | Mar 8, 2017 |
| Esteve Labs | For profit | SYN | Mar 8, 2017 |
| Eugia Pharma | For profit | SYN | Mar 29, 2012 |
| Eugia Pharma | For profit | MKTG | Jan 30, 2020 |
| Fresenius | For profit | MKTG | Jun 30, 1971 |
| Fresenius | For profit | NDA2 | Aug 25, 2014 |
| Future Pak | For profit | MKTG | Oct 22, 1987 |
| G D Searle | For profit | MKTG | Aug 12, 1982 |
| GUANGZHOU NOVAKEN | For profit | MKTG | Jan 28, 2021 |
| Genus Oncology, LLC | For profit | NDA2 | Dec 22, 2014 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jan 19, 2016 |
| Goldline | For profit | MKTG | Dec 23, 1988 |
| Granules India | For profit | MKTG | Mar 4, 2020 |
| Granules India | For profit | SYN | Oct 21, 2020 |
| Guardian Drug | For profit | MKTG | Dec 30, 2022 |
| Hikma | For profit | MKTG | Aug 1, 1994 |
| Hikma | For profit | MKTG | Sep 16, 1986 |
| Hospira | For profit | MKTG | Dec 16, 1965 |
| Hospira | For profit | SYN | Jan 3, 1978 |
| Hospira | For profit | NDA2 | Dec 16, 1965 |
| ICU Medical Inc | For profit | NDA2 | Aug 13, 1975 |
| ICU Medical Inc | For profit | MKTG | Sep 10, 2008 |
| International Medication | For profit | MKTG | Aug 29, 1975 |
| Lannett Company, Inc. | For profit | MKTG | Mar 28, 2016 |
| Lederle | For profit | MKTG | May 11, 1999 |
| Lotus Pharmaceutical | For profit | MKTG | Apr 23, 2021 |
| Lukare Medical | For profit | MKTG | Sep 27, 1996 |
| Lukare Medical | For profit | NDA2 | Sep 27, 1996 |
| Lumara Health | For profit | NDA2 | Aug 26, 1988 |
| Lupin | For profit | MKTG | Dec 18, 2015 |
| Lutipold | For profit | MKTG | Jun 30, 1981 |
| Miles | For profit | NDA2 | — |
| Miles | For profit | MKTG | — |
| Mylan | For profit | MKTG | Jan 28, 2010 |
| Mylan | For profit | SYN | Feb 5, 2004 |
| Mylan | For profit | SYN | Oct 26, 1984 |
| Mylan | For profit | SYN | Mar 29, 2012 |
| Mylan | For profit | NDA2 | Oct 26, 1984 |
| Nesher Pharms | For profit | NDA2 | Oct 17, 1980 |
| Nesher Pharms | For profit | MKTG | Feb 17, 1987 |
| Nestle | For profit | NDA2 | Oct 28, 1981 |
| Nexus Pharmaceuticals | For profit | MKTG | Mar 18, 2021 |
| Nexus Pharmaceuticals | For profit | SYN | Mar 18, 2021 |
| Norbrook | For profit | MKTG | May 9, 1986 |
| Norwich Eaton Company | For profit | MKTG | — |
| Nostrum Laboratories | For profit | MKTG | Mar 8, 2017 |
| Novartis | For profit | NDA2 | Apr 25, 1975 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | May 27, 2009 |
| Padagis Us | For profit | MKTG | May 18, 2011 |
| Paddock Laboratories | For profit | MKTG | Feb 25, 2010 |
| Paddock Laboratories | For profit | SYN | Nov 5, 2015 |
| Par Pharmaceuticals | For profit | MKTG | Dec 26, 2013 |
| Perrigo | For profit | MKTG | Feb 25, 2010 |
| Pharmaceutical Associates | For profit | MKTG | Mar 29, 2019 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | NDA2 | Aug 19, 2015 |
| Pharmaceutics International, Inc. | For profit | MKTG | Dec 8, 2015 |
| Pharmachemie Bv | For profit | MKTG | Jan 8, 2010 |
| Pharmachemie Bv | For profit | SYN | Jul 8, 1988 |
| Pharmacia & Upjohn | For profit | MKTG | Aug 23, 1991 |
| Prinston Inc | For profit | MKTG | Apr 30, 2019 |
| Rising Pharmaceuticals | For profit | MKTG | Dec 19, 2023 |
| Rubicon Research | For profit | MKTG | Jan 13, 2022 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Aug 9, 2018 |
| Salix | For profit | MKTG | Aug 2, 2006 |
| Salix | For profit | SYN | May 4, 2018 |
| Salix | For profit | SYN | May 4, 2018 |
| Salix | For profit | NDA2 | Aug 2, 2006 |
| Sandoz | For profit | MKTG | Mar 31, 2009 |
| Sandoz | For profit | SYN | Mar 31, 2009 |
| Saptalis Pharmaceuticals | For profit | MKTG | May 21, 2021 |
| Savage Labs | For profit | NDA2 | — |
| Savage Labs | For profit | MKTG | — |
| Schering | For profit | NDA2 | Jun 13, 1986 |
| Schering-Plough | For profit | NDA2 | Jun 13, 1986 |
| Sigmapharm Laboratories | For profit | MKTG | Aug 19, 2016 |
| Silvergate Pharmaceuticals | For profit | MKTG | Apr 25, 2017 |
| Strides Pharma Science | For profit | MKTG | Apr 13, 2015 |
| Sun Pharmaceuticals | For profit | MKTG | May 21, 2015 |
| TWi Biotechnology, Inc. | For profit | MKTG | Jan 12, 2018 |
| Teva | For profit | MKTG | Apr 26, 1996 |
| Tris Pharma, Inc. | For profit | MKTG | Mar 4, 2016 |
| Unichem | For profit | MKTG | Aug 21, 2020 |
| Upsher-Smith Laboratories | For profit | NDA | Apr 17, 1986 |
| Upsher-Smith Laboratories | For profit | NDA2 | Apr 17, 1986 |
| Upsher-Smith Laboratories | For profit | MKTG | Nov 20, 1998 |
| Vintage | For profit | MKTG | Jan 28, 1992 |
| Vitruvias Therapeutics | For profit | MKTG | Jan 12, 2018 |
| Watson Pharmaceuticals | For profit | MKTG | — |
| Wes Pharma Inc | For profit | MKTG | Jun 6, 2022 |
| West-Ward Pharmaceutical | For profit | MKTG | Sep 16, 1986 |
| Yichang Humanwell Pharmaceutical Co.,Ltd | For profit | MKTG | Jun 22, 2018 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 11, 2019 |