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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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Combinations
Golytely, Moviprep, Nulytely, Peg, potassium chloride, bicarbonate,, Peg, sulfate, chloride, potassium chloride, ascorbate ascorbic acid, Plenvu, Polyethylene glycol 3350 electrolytes, Suflave (discontinued: Clenz-lyte, Co-lav, Colyte with flavor packs, Go-evac, Golytely, Halflytely, Lax-lyte with flavor packs, Ocl, Peg 3350 electrolytes, Peg, potassium chloride, bicarbonate,, Peg-lyte, Polyethylene glycol 3350 electrolytes, Suclear, Trilyte)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
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
Show 5 discontinued
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
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
Tradename
Company
Number
Date
Products
NULYTELYBraintree LaboratoriesN-019797 RX1991-04-22
1 products, RLD, RS
NULYTELY-FLAVOREDBraintree LaboratoriesN-019797 RX1994-11-18
1 products, RLD, RS
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
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate
Tradename
Company
Number
Date
Products
OCLHospiraN-019284 DISCN1986-04-30
1 products
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
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 237 more
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
1358 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 cD006526B19.21022362740130
HivD0066781116102555116
Hepatitis aD006506EFO_0007305B15519312233107
InfectionsD007239EFO_00005441317201640103
Acquired immunodeficiency syndromeD000163EFO_0000765B20181217134197
AnemiaD000740HP_0001903D64.91145141383
ColonoscopyD003113419223579
ConstipationD003248HP_0002019K59.031011351774
Show 151 more
Indications Phases 3
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1426
PharmacokineticsD01059944
Medication adherenceD055118EFO_0006344112
Therapeutic equivalencyD013810112
DiverticulitisD004238EFO_1001460K57112
WartsD014860B07112
Laron syndromeD046150Orphanet_633E34.32122
Macular degenerationD008268EFO_0001365H35.3011
Wet macular degenerationD057135EFO_000468311
Reticulocyte countD01770111
Show 19 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HelminthiasisD006373EFO_1001342B65-B8344
Disease progressionD01845044
Mental disordersD001523EFO_0000677F91.944
Opportunistic infectionsD00989433
Multidrug-resistant tuberculosisD018088EFO_000738133
Fecal incontinenceD005242R1533
Chronic painD059350HP_001253233
Risk-takingD01230922
DermatitisD003872HP_0011123L30.922
KeratoconjunctivitisD007637H16.222
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 29,492 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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