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Drug ReportsPolyethylene glycol 3350
Polyethylene glycol 3350
/ Polyethylene Glycol 3350 / Potassium / / /, Clenz-lyte, Golytely, Halflytely, Miralax, Moviprep, Nulytely, Ocl, Plenvu, Polyethylene Glycol, Polyethylene Glycol 3350 / Potassium / Bicarbonate /, Polyethylene Glycol 3350 / Potassium / Bicarbonate / /, Suclear, Suflave (polyethylene glycol 3350) is a small molecule pharmaceutical. Polyethylene glycol 3350 was first approved as Golytely on 1984-07-13. It is used to treat constipation in the USA.
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Drug
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Financial
Trends
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5D
1M
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6M
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Miralax (generic drugs available since 2009-06-01, discontinued: Glycolax)
Combinations
Colyte with flavor packs, Golytely, Moviprep, Nulytely, Plenvu, Suflave (generic drugs available since 2009-06-01, discontinued: Clenz-lyte, Co-lav, Colovage, Colyte, E-z-em prep lyte, Glycoprep, Go-evac, Halflytely, Lax-lyte with flavor packs, Ocl, Peg-lyte, Suclear, Trilyte)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ascorbic acid
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium ascorbate
+
Sodium chloride
+
Sodium sulfate
Tradename
Company
Number
Date
Products
PLENVUSalix PharmaceuticalsN-209381 RX2018-05-04
1 products, RLD, RS
MOVIPREPSalix PharmaceuticalsN-021881 RX2006-08-02
1 products, RLD, RS
Bisacodyl
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
Tradename
Company
Number
Date
Products
HALFLYTELYBraintree LaboratoriesN-021551 DISCN2010-07-16
1 products, RLD
Hide discontinued
Magnesium sulfate
+
Polyethylene glycol 3350
+
Potassium chloride
+
Potassium sulfate
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate
Tradename
Company
Number
Date
Products
SUCLEARBraintree LaboratoriesN-203595 DISCN2013-01-18
1 products, RLD
Hide discontinued
Magnesium sulfate
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium chloride
+
Sodium sulfate
Tradename
Company
Number
Date
Products
SUFLAVEBraintree LaboratoriesN-215344 RX2023-06-15
1 products, RLD, RS
Polyethylene glycol 3350
Tradename
Company
Number
Date
Products
MIRALAXBayerN-022015 OTC2006-10-06
1 products, RLD, RS
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
Tradename
Company
Number
Date
Products
NULYTELY-FLAVOREDBraintree LaboratoriesN-019797 RX1994-11-18
1 products, RLD, RS
NULYTELYBraintree LaboratoriesN-019797 RX1991-04-22
1 products, RLD, RS
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate
Tradename
Company
Number
Date
Products
OCLHospiraN-019284 DISCN1986-04-30
1 products
Hide discontinued
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate anhydrous
Tradename
Company
Number
Date
Products
GOLYTELYBraintree LaboratoriesN-019011 RX1984-07-13
1 products, RLD, RS
COLYTE WITH FLAVOR PACKSMylanN-018983 RX1998-10-08
1 products
Show 3 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
advance relief eye dropsOTC monograph final2019-12-06
advanced reliefOTC monograph final2023-02-17
archies dry eye reliefC2002632023-11-15
artificial tearsOTC monograph final2019-10-28
assured advanced relief eyeOTC monograph final2013-02-28
avenova lubricant eye drops high performanceC2002632023-12-23
basic care clearlaxANDA2023-01-24
basic care eyeOTC monograph final2023-02-15
berkley and jensen clearlaxANDA2023-05-12
best choice eye drops advanced reliefC2002632023-12-23
Show 235 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
constipationHP_0002019D003248K59.0
common coldEFO_0007214D003139J00
methemoglobinemia—D008708D74
penetrating wounds—D014950—
tyrosinemias—D020176E70.21
scurvyEFO_1001169D012614E54
Agency Specific
FDA
EMA
Expiration
Code
MAGNESIUM SULFATE / POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM SULFATE, SUFLAVE, BRAINTREE LABS
2026-06-15NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / Sodium Sulfate, Plenvu, Salix
89993132033-09-10DP
93269692033-09-10U-2310
97072972033-09-10DP
100165042033-09-10DP
109187232033-09-10U-2310
95922522032-08-11DPU-2310
106465122032-03-25DP
107801122032-03-09DP
107923062032-03-09DPU-2310
115293682032-03-09DPU-2310
Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / Sodium Sulfate, Moviprep, Salix Pharms
71693812024-09-01DS, DP
76589142024-09-01DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A06: Drugs for constipation
— A06A: Drugs for constipation
— A06AD: Osmotically acting laxatives
— A06AD15: Macrogol
— A06AD65: Macrogol, combinations
HCPCS
No data
Clinical
Clinical Trials
1353 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B205748505799297
HepatitisD006505HP_0012115K75.9727392647139
Hepatitis cD006526—B19.21022362740130
HivD006678——111692555115
Hepatitis aD006506EFO_0007305B15519312233107
InfectionsD007239EFO_0000544—1317201639102
Acquired immunodeficiency syndromeD000163EFO_0000765B20181217134096
AnemiaD000740HP_0001903D64.9—1145141383
ColonoscopyD003113———419223579
ConstipationD003248HP_0002019K59.031011351774
Show 151 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C9592121—247
Precursor cell lymphoblastic leukemia-lymphomaD054198——91820—244
Lymphoid leukemiaD007945—C9191819—243
Covid-19D000086382——279—320
Diabetes mellitusD003920HP_0000819E08-E13—15—511
Precursor t-cell lymphoblastic leukemia-lymphomaD054218——235——9
Hepatocellular carcinomaD006528—C22.0211—59
Liver neoplasmsD008113EFO_1001513C22.02—1—69
HepacivirusD016174——115—18
RecurrenceD012008——241—17
Show 73 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13—1——1011
Lung neoplasmsD008175HP_0100526C34.9024——28
Non-small-cell lung carcinomaD002289——14——16
PneumoniaD011014EFO_0003106—13——25
Autistic disorderD001321HP_0000717F84.014——15
Autism spectrum disorderD000067877HP_0000729F84.014——15
AdenocarcinomaD000230——32——25
SclerosisD012598——22——14
Postoperative painD010149—G89.18—2——24
Type 1 diabetes mellitusD003922EFO_0001359E10—2——13
Show 78 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.14———26
PharmacokineticsD010599——4————4
Medication adherenceD055118EFO_0006344—1———12
Therapeutic equivalencyD013810——1———12
DiverticulitisD004238EFO_1001460K571———12
WartsD014860—B071———12
Laron syndromeD046150Orphanet_633E34.3212————2
Macular degenerationD008268EFO_0001365H35.301————1
Wet macular degenerationD057135EFO_0004683—1————1
Reticulocyte countD017701——1————1
Show 19 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HelminthiasisD006373EFO_1001342B65-B83————44
Disease progressionD018450——————44
Mental disordersD001523EFO_0000677F91.9————44
Opportunistic infectionsD009894——————33
Fecal incontinenceD005242—R15————33
Chronic painD059350HP_0012532—————33
Risk-takingD012309——————22
DermatitisD003872HP_0011123L30.9————22
KeratoconjunctivitisD007637—H16.2————22
AnxietyD001007EFO_0005230F41.1————22
Show 107 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePolyethylene glycol 3350
INNmacrogol
Description
Macrogol, also known as polyethylene glycol (PEG), is used as a medication to treat constipation in children and adults. It is taken by mouth. Benefits usually occur within three days. Generally it is only recommended for up to two weeks. It is also used as an excipient. It is also used to clear the bowels (known as "bowel prep") before a colonoscopy, when the onset of the laxative effect is more rapid, typically within an hour.
Classification
Small molecule
Drug classOsmotic laxative
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201479
ChEBI ID—
PubChem CID—
DrugBankDB09287
UNII ID3WJQ0SDW1A (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 28,042 documents
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Safety
Black-box Warning
Black-box warning for: Mircera
Adverse Events
Top Adverse Reactions
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59,150 adverse events reported
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