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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 reliefC2002632024-12-31
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
berkley and jensen clearlaxANDA2023-05-12
best choice eye drops advanced reliefC2002632023-12-23
blink gel tearsC2002632024-09-20
Show 233 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
constipation—D003248K59.0
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
1379 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ColonoscopyD003113———184—13
ConstipationD003248—K59.0———7—7
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colonic neoplasmsD003110—C18——2——2
EndoscopyD004724————1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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 34,895 documents
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Safety
Black-box Warning
Black-box warning for: Mircera
Adverse Events
Top Adverse Reactions
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62,427 adverse events reported
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