sodium chloride

Small moleculeapproved

Approved

Dec 7, 1953

Saline is a mixture of sodium chloride (salt) and water. It has several uses in medicine including cleaning wounds, removal and storage of contact lenses, and help with dry eyes. By injection into a vein, it is used to treat hypovolemia such as that from gastroenteritis and diabetic ketoacidosis. Large amounts may result in fluid overload, swelling, acidosis, and high blood sodium. In those with long-standing low blood sodium, excessive use may result in osmotic demyelination syndrome. — Wikipedia

Clinical trial activity

3,159 trials · 1,751 clinical orgs · 94 marketing orgs

Phase 1

445

Phase 2

1026

Phase 3

532

Phase 4

781

Earliest trial started Feb 1, 1993 (NCT00009620)

Timeline

1950s

Dec 7, 1953
Evidence of US Marketing
Dec 7, 1953
Earliest FDA Approval
Dec 7, 1953
DAVA Pharmaceuticals — Marketing Organization

1960s

Dec 16, 1965
Hospira — First NDA Organization
Dec 16, 1965
Hospira — NDA Secondary Org
Dec 16, 1965
Hospira — NDA Organization

1970s

Aug 12, 1970
B. Braun — NDA Secondary Org
Dec 8, 1970
Baxalta — NDA Secondary Org
Dec 8, 1970
Baxter — NDA Secondary Org
Oct 8, 1971
Abbott — NDA Secondary Org
Feb 24, 1972
ICU Medical Inc — NDA Secondary Org
Sep 5, 1979
Bristol-Myers — Marketing Organization

1980s

Aug 25, 1980
Hospira — Marketing Organization
Sep 3, 1980
Fresenius — NDA Secondary Org
Oct 28, 1981
Alcon — Marketing Organization
Oct 28, 1981
Nestle — NDA Secondary Org
Jul 13, 1984
Braintree Laboratories — Marketing Organization
Jul 13, 1984
Braintree Laboratories — NDA Secondary Org
Oct 26, 1984
Mylan — NDA Secondary Org
Feb 14, 1985
Bristol-Myers Squibb — Marketing Organization
May 9, 1986
Norbrook — Marketing Organization
Jun 13, 1986
Abraxis — Marketing Organization
Apr 20, 1988
Dynapharm — Marketing Organization
Dec 23, 1988
Goldline — 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
Nov 27, 1991
Epic Pharma Llc — NDA Secondary Org
Jan 28, 1992
Vintage — Marketing Organization
Sep 3, 1992
Blairex — NDA Secondary Org
Jan 1, 1993
Earliest Phase 3 Sponsor(trial)
Jun 13, 1994
Fresenius — Marketing Organization
Jan 1, 1996
Earliest Phase 1 Sponsor(trial)
Sep 27, 1996
Lukare Medical — Marketing Organization
Sep 27, 1996
Lukare Medical — NDA Secondary Org
Dec 20, 1996
Johnson and Johnson — Marketing Organization
Jun 17, 1999
Duramed Research — Marketing Organization

2000s

Jan 1, 2000
Earliest Phase 2 Sponsor(trial)
Apr 21, 2000
Baxter — Marketing Organization
Aug 18, 2000
Santen Inc. — Marketing Organization
Oct 27, 2004
Haemonetics Corporation — Marketing Organization
Jun 20, 2005
Sicor — Marketing Organization
Jun 20, 2005
Teva — NDA Secondary Org
Jul 26, 2006
Henry Schein, Inc — NDA Secondary Org
Jul 26, 2006
Watson Pharmaceuticals — NDA Secondary Org
Jul 27, 2006
Liebel-Flarsheim — NDA Secondary Org
Jul 27, 2006
International Minerals and Chemical Corporation — NDA Secondary Org
Aug 2, 2006
Salix — Marketing Organization
Aug 2, 2006
Salix — NDA Secondary Org
Aug 11, 2006
Taro Pharmaceuticals — Marketing Organization
Oct 25, 2006
Baxalta — Marketing Organization
Apr 30, 2007
Accord Research — Marketing Organization
Sep 10, 2008
ICU Medical Inc — 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 3, 2010
B. Braun — Marketing Organization
Feb 25, 2010
Paddock Laboratories — Marketing Organization
Feb 25, 2010
Perrigo — Marketing Organization
Dec 1, 2010
Bedford Pharmaceuticals — Marketing Organization
Dec 20, 2010
ANDA Repository — Marketing Organization
Dec 20, 2010
Apotex — Marketing Organization
Dec 20, 2010
Rising Pharmaceuticals — Marketing Organization
Dec 20, 2010
Rubicon Research — Marketing Organization
Jun 20, 2011
Aurobindo Pharma — Marketing Organization
Jun 20, 2011
Celltrion — Marketing Organization
Jun 20, 2011
Dr. Reddy's Laboratories — Marketing Organization
Jun 20, 2011
Glenmark Pharmaceuticals — Marketing Organization
Jun 20, 2011
Hi Tech Pharmaceuticals — Marketing Organization
Jun 20, 2011
Lupin — Marketing Organization
Jun 20, 2011
Sandoz — Marketing Organization
Jun 20, 2011
Teva — Marketing Organization
Jun 20, 2011
Torrent Pharmaceuticals Limited — Marketing Organization
Jun 20, 2011
Novitium Pharma — Marketing Organization
Jul 7, 2011
Inforlife — Marketing Organization
Sep 16, 2011
Hikma — Marketing Organization
Jan 6, 2012
Medefil — NDA Secondary Org
Jan 20, 2012
West-Ward Pharmaceutical — Marketing Organization
Jan 30, 2012
Orchid Pharma — Marketing Organization
Jan 30, 2012
Orbion Pharms — Marketing Organization
Mar 22, 2012
Macleods Pharmaceuticals, Ltd — Marketing Organization
Mar 30, 2012
Cipla — Marketing Organization
Mar 30, 2012
Chartwell Pharmaceuticals — Marketing Organization
Sep 7, 2012
Cadila Healthcare — Marketing Organization
Jan 24, 2013
Emcure — Marketing Organization
Jan 24, 2013
Avet Lifesciences — Marketing Organization
Nov 22, 2013
Watson Pharmaceuticals — Marketing Organization
Jan 8, 2015
Hetero Labs Ltd — Marketing Organization
Apr 13, 2015
Strides Pharma Science — Marketing Organization
May 21, 2015
Sun Pharmaceuticals — Marketing Organization
May 18, 2016
Jubilant Clinsys, Inc — Marketing Organization
May 18, 2016
Jubilant Innovation Ltd. — Marketing Organization
Mar 8, 2017
Esteve Labs — Marketing Organization
Mar 8, 2017
Nostrum Laboratories — Marketing Organization
Apr 25, 2017
Silvergate Pharmaceuticals — Marketing Organization
Apr 25, 2017
Azurity — Marketing Organization
May 25, 2017
Grifols — Marketing Organization
Jun 1, 2017
Zydus Discovery DMCC — Marketing Organization
Jul 21, 2017
Spectra Medical Devices — Marketing Organization
Dec 22, 2017
Amneal Pharmaceuticals — Marketing Organization
May 4, 2018
Bausch Health Companies — NDA Secondary Org
May 25, 2018
Lannett Company, Inc. — Marketing Organization
Aug 9, 2018
Sagent Pharmaceuticals, Inc. — Marketing Organization
Feb 5, 2019
Sunshine Lake Pharma Co., Ltd. — Marketing Organization
Feb 27, 2019
Micro Labs Ltd India — Marketing Organization

2020s

Jan 30, 2020
Eugia Pharma — Marketing Organization
Apr 22, 2020
Gland Pharma Ltd — Marketing Organization
Apr 23, 2020
Nephron Pharmaceuticals Corporation — Marketing Organization
Apr 23, 2021
Lotus Pharmaceutical — Marketing Organization
Aug 7, 2023
Daito Pharmaceuticals — Marketing Organization
Aug 23, 2023
Nexus Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

ElectrolyteSupplementation
Electrolyte supplementation

Combination products

acetated ringer's
with potassium chloride, sodium acetate, calcium chloride
aminosyn ii m in dextrose
with potassium chloride, amino acids, sodium phosphate, glucose monohydrate, magnesium
aminosyn ii w/ elect and adjusted phosphate in dextrose
with potassium chloride, amino acids, potassium acetate, potassium phosphate, glucose monohydrate, magnesium
aminosyn ii w/ electrolytes
with potassium chloride, amino acids, potassium phosphate, magnesium
aminosyn ii w/ electrolytes in dextrose
with potassium chloride, amino acids, potassium phosphate, glucose monohydrate, magnesium
aminosyn ii w/ electrolytes in dextrose w/ calcium
with potassium chloride, amino acids, calcium chloride, potassium phosphate, glucose monohydrate, magnesium
aminosyn m
with phosphoric acid, amino acids, potassium acetate, magnesium
aminosyn w/electrolytes
with potassium chloride, amino acids, sodium phosphate, magnesium
Also known as aminosyn ii m, aminosyn ii w/electrolytes
aminosyn w/ electrolytes
with amino acids, potassium phosphate, magnesium
bss plus
with potassium chloride, sodium bicarbonate, sodium phosphate, calcium chloride, glucose monohydrate, glutathione, magnesium
Also known as methotrexate sodium
clinimix e 4.25/25 sulfite free w/ elect in dextrose w/ calcium
with sodium acetate, amino acids, calcium chloride, potassium phosphate, glucose monohydrate, magnesium
Also known as clinimix e 2.75/10 sulfite free w/ elect in dextrose w/ calcium, clinimix e 2.75/25 sulfite free w/ elect in dextrose w/ calcium, clinimix e 2.75/5 sulfite free w/ elect in dextrose w/ calcium, clinimix e 4.25/10 sulfite free w/ elect in dextrose w/ calcium, clinimix e 4.25/20 sulfite free w/ elect in dextrose w/ calcium, clinimix e 4.25/5 sulfite free w/ elect in dextrose w/ calcium, clinimix e 5/10 sulfite free w/ elect in dextrose w/ calcium, clinimix e 5/15 sulfite free w/ elect in dextrose w/ calcium, clinimix e 5/20 sulfite free w/ elect in dextrose w/ calcium, clinimix e 5/25 sulfite free w/ elect in dextrose w/ calcium, clinimix e 5/35 sulfite free w/ elect in dextrose w/ calcium
dextrose and electrolyte
with potassium chloride, lactic acid, potassium phosphate, glucose monohydrate, magnesium
dextrose in acetated ringer's
with potassium chloride, sodium acetate, calcium chloride, glucose monohydrate
dextrose in ringer's
with potassium chloride, calcium chloride, glucose monohydrate
Also known as dextrose and ringer's
dialyte w/ dextrose
with sodium acetate, calcium chloride, glucose monohydrate, magnesium
Also known as dialyte concentrate w/ dextrose
dianeal low calcium w/dextrose
with lactic acid, calcium chloride, glucose monohydrate, magnesium
Also known as delflex-lm w/ dextrose, delflex w/ dextrose, delflex w/ dextrose low magnesium, delflex w/ dextrose low magnesium low calcium, dianeal 137 w/ dextrose, dianeal low calcium w/ dextrose, dianeal pd-1 w/ dextrose, dianeal pd-2 w/ dextrose, inpersol-lc/lm w/ dextrose
elliotts b solution
with potassium chloride, magnesium sulfate, sodium bicarbonate, sodium phosphate, calcium chloride, glucose monohydrate
freamine iii w/ electrolytes
with potassium chloride, phosphoric acid, sodium acetate, amino acids, magnesium
golytely
with potassium chloride, sodium sulfate, sodium bicarbonate, 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, potassium chloride, sodium bicarbonate, polyethylene glycol
Also known as peg-3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl
inpersol-zm w/ dextrose
with lactic acid, calcium chloride, glucose monohydrate
ionosol b and dextrose
with potassium chloride, lactic acid, sodium phosphate, potassium phosphate, glucose monohydrate, magnesium
ionosol t and dextrose
with potassium chloride, sodium phosphate, potassium lactate, glucose monohydrate
isolyte e
with sodium citrate, potassium chloride, sodium acetate, calcium chloride, magnesium
Also known as balanced salt, bss
isolyte e w/ dextrose
with sodium citrate, potassium chloride, sodium acetate, calcium chloride, glucose monohydrate, magnesium
Also known as isolyte e in dextrose
isolyte h w/ dextrose
with potassium chloride, sodium acetate, glucose monohydrate, magnesium
Also known as isolyte h in dextrose
isolyte m w/ dextrose
with potassium chloride, sodium acetate, potassium phosphate, glucose monohydrate
Also known as isolyte m in dextrose
isolyte r w/ dextrose
with potassium chloride, sodium acetate, calcium chloride, glucose monohydrate, magnesium
Also known as isolyte r in dextrose
isolyte s ph
with potassium chloride, sodium acetate, sodium phosphate, potassium phosphate, sodium gluconate, magnesium
lactated ringer's
with potassium chloride, lactic acid, calcium chloride
lactated ringer's and dextrose
with potassium chloride, lactic acid, 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
levofloxacin
with levofloxacin
moviprep
with vitamin c, potassium chloride, sodium sulfate, polyethylene glycol
Also known as peg-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic aci, plenvu
navstel
with potassium chloride, sodium bicarbonate, sodium phosphate, oxiglutatione, calcium chloride, glucose monohydrate, magnesium
normocarb hf
with sodium bicarbonate, magnesium
normosol-m and dextrose
with potassium acetate, glucose monohydrate, magnesium
Also known as plasma-lyte 56 and dextrose
normosol-r
with potassium chloride, sodium acetate, sodium gluconate, magnesium
Also known as isolyte s, physiolyte, physiosol, physiosol ph, plasma-lyte a
normosol-r and dextrose
with potassium chloride, sodium acetate, glucose monohydrate, sodium gluconate, magnesium
Also known as isolyte s in dextrose, isolyte s w/ dextrose, plasma-lyte 148 and dextrose
nulytely-flavore
with potassium chloride, sodium bicarbonate, polyethylene glycol
Also known as lax-lyte with flavor packs, nulytely, peg-3350, potassium chloride, sodium bicarbonate, sodium chloride, trilyte
phoxillum bk
with potassium chloride, sodium bicarbonate, sodium phosphate, calcium chloride, magnesium
Also known as phoxillum b22k
plasma-lyte m and dextrose
with potassium chloride, sodium acetate, lactic acid, calcium chloride, glucose monohydrate, magnesium
plasma-lyte r
with potassium chloride, sodium acetate, lactic acid, calcium chloride, magnesium
plegisol
with potassium chloride, calcium chloride, magnesium
Also known as cardioplegic
prismasol bk
with potassium chloride, lactic acid, sodium bicarbonate, calcium chloride, glucose monohydrate, magnesium
Also known as prismasol b22gk, prismasol bgk
procalamine
with glycerin, calcium, potassium chloride, phosphoric acid, sodium acetate, amino acids, magnesium
ringer's
with potassium chloride, calcium chloride
suclear
with potassium chloride, magnesium sulfate, potassium sulfate, sodium sulfate, sodium bicarbonate, polyethylene glycol
suflave
with potassium chloride, magnesium sulfate, sodium sulfate, polyethylene glycol
tham-e
with potassium chloride, tromethamine
tis-u-sol
with potassium chloride, magnesium sulfate, sodium phosphate, potassium phosphate
tpn electrolytes
with potassium chloride, sodium acetate, calcium chloride, magnesium
travasol sulfite free w/ electrolytes in dextrose
with sodium acetate, amino acids, potassium phosphate, glucose monohydrate, magnesium
travasol w/ electrolytes
with sodium acetate, amino acids, potassium phosphate, magnesium
Also known as travasol sulfite free w/ electrolytes

Approval history

approvedPriority reviewDec 7, 1953
approvedPriority reviewDec 7, 1953

Chemistry & pharmacology

Loading structure…

SMILES

[Na+].[Cl-]

Mol. weight: 58.443 g/mol
Chirality: Achiral Molecule
Inorganic: Yes
Polymer: No
Delivery: Oral, Parenteral, Topical
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Sources

Also known as

10% sodium chloride injection
10% sodium chloride injection
aqsia (balanced salt soln)
askina
askina jet
balanced salt
bio-25
broncho saline
broncho saline
bss (balanced salt soln)
compound solution of sodium chloride
flowfusor
fresenius
fresenius
glucion
hypertonic saline
hypromellose in ringers soln
iocare (balanced salt soln)
irriclens
isotonic
isotonic
isot saline
labmist
lcd
lockes
macoperf
miniversol
muro 128
natrium chloratum
natrium chloride
nine lives
normasol
normosol r
normosol r
oft cusi antiedema
optiflo s
physiomer
ringer-locke
ringer's
ringer's
salex
salex
saline
saline
saline
saline steripoule
salinex
salinex
salline
salt
salt
s-chlor sf
slow sod
sodiclor
sodium chloride
sodium chloride
sodium chloride
sodium chloride
sodium chloride
sodium chloride
sodium chloride
sodium chloride
sodium chloride
sodium chloride, hypertonic
sodium chloride, hypertonic
sodium chloride solution
sodium chloride solution
sodium chloride solution
sterac
sterijet
steri-wash
syrisal
table salt
table salt
topiclens
tubilux
uriflex-s
uriflex-sp
uroclens
vitaclean

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06825143	Early Phase 1 (Phase 1)	Oct 1, 2026	Western Colorado University
NCT06872060	N/A	Jun 1, 2026	University of Copenhagen
NCT07224711	Phase 4	Jun 1, 2026	Vanderbilt University
NCT07267897	N/A	Mar 15, 2026	Sakarya University
NCT07214103	Phase 2	Mar 1, 2026	University of Strasbourg
NCT07236086	N/A	Jan 31, 2026	Assiut University
NCT07270874	Phase 4	Jan 31, 2026	University of Barcelona
NCT07059091	Phase 2	Jan 31, 2026	American Lung Association, Genentech, Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID)
NCT07077746	Phase 2	Jan 31, 2026	Hope Biosciences
NCT07126795	Phase 1	Jan 1, 2026	Hennepin Healthcare
NCT07267650	N/A	Jan 1, 2026	Turgutlu State Hospital
NCT07278661	Phase 2	Jan 1, 2026	University of Nantes
NCT07055087	Phase 2	Dec 31, 2025	University of Tuebingen
NCT07294807	N/A	Dec 25, 2025	Peking University
NCT06926764	N/A	Nov 30, 2025	Chinese University of Hong Kong, Government of Hong Kong
NCT07202000	Phase 2	Nov 1, 2025	American Heart Association, Harvard University, Oakland University, University of Michigan
NCT07167693	Phase 1/Phase 2 (Phase 2)	Nov 1, 2025	Wayne State University
NCT07188766	N/A	Oct 31, 2025	Imam Abdulrahman Bin Faisal University
NCT07150481	Phase 2/Phase 3 (Phase 3)	Oct 31, 2025	Assiut University
NCT06968806	Phase 3	Oct 27, 2025	Harbin Medical University, Henan Provincial Chest Hospital, Huai'an First People's Hospital, Nanjing University, Shandong Provincial Hospital, Shantou University

Showing 20 of 3,159 trials

Page 1 / 158

Organizations

Research & Development (1,751)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
University of Copenhagen	Academic/Hospital	97	87	5	2004
Yonsei University	Academic/Hospital	62	60	4	2010
University of Toronto	Academic/Hospital	59	45	5	1999
Harvard University	Academic/Hospital	49	44	5	2004
Seoul National University	Academic/Hospital	45	41	5	2006
Aarhus University	Academic/Hospital	42	35	5	2005
Allergan	For profit	42	28	5	2003
Assiut University	Academic/Hospital	36	36	4	2009
People's Liberation Army of China	Government	36	22	5	2008
University of London	Academic/Hospital	36	24	5	2004
Northwestern University	Academic/Hospital	35	33	5	2007
Jiao Tong University	Academic/Hospital	33	27	5	2008
GlaxoSmithKline	For profit	32	27	5	2004
Vanderbilt University	Academic/Hospital	32	26	5	1997
Mayo Clinic	Academic/Hospital	29	27	5	1998
Cairo University	Academic/Hospital	28	27	5	2010
Johns Hopkins University	Academic/Hospital	27	21	5	2003
Poznan University	Academic/Hospital	24	22	2	2020
National Heart, Lung, and Blood Institute (NHLBI)	Government	23	0	4	2001
University of Pittsburgh	Academic/Hospital	23	18	5	2006

1,751 organizations

Page 1 / 88

Marketing (132)

Organization	Org type	Relationship	Date
ANDA Repository	For profit	MKTG	Dec 20, 2010
Abbott	For profit	NDA2	Oct 8, 1971
Abraxis	For profit	MKTG	Jun 13, 1986
Abraxis	For profit	NDA2	—
Accord Research	For profit	MKTG	Apr 30, 2007
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
Amneal Pharmaceuticals	For profit	MKTG	Dec 22, 2017
Apotex	For profit	MKTG	Dec 20, 2010
Aurobindo Pharma	For profit	MKTG	Jun 20, 2011
Aurobindo Pharma	For profit	SYN	Feb 5, 2004
Avet Lifesciences	For profit	MKTG	Jan 24, 2013
Azurity	For profit	MKTG	Apr 25, 2017
B. Braun	For profit	NDA2	Aug 12, 1970
B. Braun	For profit	MKTG	Feb 3, 2010
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	Dec 8, 1970
Baxter	For profit	NDA2	Dec 8, 1970
Baxter	For profit	MKTG	Apr 21, 2000
Bedford Pharmaceuticals	For profit	MKTG	Dec 1, 2010
Blairex	For profit	NDA2	Sep 3, 1992
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	Feb 14, 1985
Bristol-Myers Squibb	For profit	SYN	Apr 14, 1989
Cadila Healthcare	For profit	MKTG	Sep 7, 2012
Celltrion	For profit	MKTG	Jun 20, 2011
Chartwell Pharmaceuticals	For profit	MKTG	Mar 30, 2012
Cipla	For profit	MKTG	Mar 30, 2012
DAVA Pharmaceuticals	For profit	MKTG	Dec 7, 1953
Daito Pharmaceuticals	For profit	MKTG	Aug 7, 2023
Dr. Reddy's Laboratories	For profit	MKTG	Jun 20, 2011
Duramed Research	For profit	MKTG	Jun 17, 1999
Dynapharm	For profit	MKTG	Apr 20, 1988
E Z EM	For profit	MKTG	—
Emcure	For profit	MKTG	Jan 24, 2013
Epic Pharma Llc	For profit	NDA2	Nov 27, 1991
Esteve Labs	For profit	MKTG	Mar 8, 2017
Esteve Labs	For profit	SYN	Mar 8, 2017
Eugia Pharma	For profit	MKTG	Jan 30, 2020
Eugia Pharma	For profit	SYN	Mar 29, 2012
Fresenius	For profit	MKTG	Jun 13, 1994
Fresenius	For profit	SYN	Sep 3, 1980
Fresenius	For profit	SYN	Jan 10, 1985
Fresenius	For profit	NDA2	Sep 3, 1980
Gland Pharma Ltd	For profit	MKTG	Apr 22, 2020
Glenmark Pharmaceuticals	For profit	MKTG	Jun 20, 2011
Goldline	For profit	MKTG	Dec 23, 1988
Grifols	For profit	MKTG	May 25, 2017
Haemonetics Corporation	For profit	MKTG	Oct 27, 2004
Henry Schein, Inc	For profit	NDA2	Jul 26, 2006
Hetero Labs Ltd	For profit	MKTG	Jan 8, 2015
Hi Tech Pharmaceuticals	For profit	MKTG	Jun 20, 2011
Hikma	For profit	MKTG	Sep 16, 2011
Hikma	For profit	SYN	Jan 31, 2011
Hikma	For profit	SYN	Aug 1, 1994
Hospira	For profit	NDA2	Dec 16, 1965
Hospira	For profit	MKTG	Aug 25, 1980
Hospira	For profit	NDA	Dec 16, 1965
ICU Medical Inc	For profit	NDA2	Feb 24, 1972
ICU Medical Inc	For profit	MKTG	Sep 10, 2008
Inforlife	For profit	MKTG	Jul 7, 2011
International Minerals and Chemical Corporation	For profit	NDA2	Jul 27, 2006
Johnson and Johnson	For profit	MKTG	Dec 20, 1996
Jubilant Clinsys, Inc	For profit	MKTG	May 18, 2016
Jubilant Innovation Ltd.	For profit	SYN	May 18, 2016
Jubilant Innovation Ltd.	For profit	SYN	Jun 19, 2015
Jubilant Innovation Ltd.	For profit	MKTG	May 18, 2016
Lannett Company, Inc.	For profit	MKTG	May 25, 2018
Liebel-Flarsheim	For profit	NDA2	Jul 27, 2006
Lotus Pharmaceutical	For profit	MKTG	Apr 23, 2021
Lukare Medical	For profit	MKTG	Sep 27, 1996
Lukare Medical	For profit	NDA2	Sep 27, 1996
Lupin	For profit	MKTG	Jun 20, 2011
Macleods Pharmaceuticals, Ltd	For profit	MKTG	Mar 22, 2012
Medefil	For profit	NDA2	Jan 6, 2012
Micro Labs Ltd India	For profit	MKTG	Feb 27, 2019
Miles	For profit	NDA2	—
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	Jun 20, 2011
Mylan	For profit	SYN	Dec 8, 2017
Mylan	For profit	SYN	Dec 4, 2009
Mylan	For profit	NDA2	Oct 26, 1984
Nephron Pharmaceuticals Corporation	For profit	MKTG	Apr 23, 2020
Nestle	For profit	NDA2	Oct 28, 1981
Nexus Pharmaceuticals	For profit	MKTG	Aug 23, 2023
Norbrook	For profit	MKTG	May 9, 1986
Nostrum Laboratories	For profit	MKTG	Mar 8, 2017
Novel Anti-Infective Technologies, LLC	For profit	MKTG	May 27, 2009
Novitium Pharma	For profit	MKTG	Jun 20, 2011
Orbion Pharms	For profit	MKTG	Jan 30, 2012
Orchid Pharma	For profit	MKTG	Jan 30, 2012
Paddock Laboratories	For profit	MKTG	Feb 25, 2010
Perrigo	For profit	MKTG	Feb 25, 2010
Pharmachemie Bv	For profit	MKTG	Jan 8, 2010
Pharmachemie Bv	For profit	SYN	Jul 8, 1988
Pharmacia & Upjohn	For profit	MKTG	Aug 23, 1991
Rising Pharmaceuticals	For profit	MKTG	Dec 20, 2010
Rubicon Research	For profit	MKTG	Dec 20, 2010
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	Jun 20, 2011
Sandoz	For profit	SYN	Mar 31, 2009
Santen Inc.	For profit	MKTG	Aug 18, 2000
Sicor	For profit	MKTG	Jun 20, 2005
Silvergate Pharmaceuticals	For profit	MKTG	Apr 25, 2017
Spectra Medical Devices	For profit	MKTG	Jul 21, 2017
Strides Pharma Science	For profit	MKTG	Apr 13, 2015
Sun Pharmaceuticals	For profit	MKTG	May 21, 2015
Sunshine Lake Pharma Co., Ltd.	For profit	MKTG	Feb 5, 2019
Taro Pharmaceuticals	For profit	MKTG	Aug 11, 2006
Teva	For profit	MKTG	Jun 20, 2011
Teva	For profit	SYN	Feb 10, 2011
Teva	For profit	NDA2	Jun 20, 2005
Torrent Pharmaceuticals Limited	For profit	MKTG	Jun 20, 2011
Vintage	For profit	MKTG	Jan 28, 1992
Watson Pharmaceuticals	For profit	MKTG	Nov 22, 2013
Watson Pharmaceuticals	For profit	NDA2	Jul 26, 2006
West-Ward Pharmaceutical	For profit	MKTG	Jan 20, 2012
Zydus Discovery DMCC	For profit	MKTG	Jun 1, 2017
Zydus Discovery DMCC	For profit	SYN	Sep 7, 2012