POLYETHYLENE GLYCOL 3350 / Potassium Chloride / Sodium Bicarbonate / Sodium Chloride Powder for Oral Solution

Brand(s)
GaviLyte-N, NuLytely, TriLyte
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Braintree Laboratories, Inc. (2013-09-30)
Oldest Current Product
2004-06-24
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
POWDER FOR ORAL SOLUTION\POLYETHYLENE GLYCOL 3350:POTASSIUM CHLORIDE:SODIUM BICARBONATE:SODIUM CHLORIDE
FDAOB
ORAL\FOR SOLUTION\POLYETHYLENE GLYCOL 3350: POTASSIUM CHLORIDE: SODIUM BICARBONATE: SODIUM CHLORIDE
SPL Active
NASOGASTRIC\POWDER, FOR SOLUTION\POLYETHYLENE GLYCOL 3350: POTASSIUM CHLORIDE: SODIUM BICARBONATE: SODIUM CHLORIDE
ORAL\POWDER, FOR SOLUTION\POLYETHYLENE GLYCOL 3350: POTASSIUM CHLORIDE: SODIUM BICARBONATE: SODIUM CHLORIDE
SPL Moiety
NASOGASTRIC\POWDER, FOR SOLUTION\POLYETHYLENE GLYCOL 3350: POTASSIUM CATION: SODIUM CATION
ORAL\POWDER, FOR SOLUTION\BICARBONATE ION: CHLORIDE ION: POLYETHYLENE GLYCOL 3350
ORAL\POWDER, FOR SOLUTION\CHLORIDE ION: POLYETHYLENE GLYCOL 3350: POTASSIUM CATION: SODIUM CATION

product(s) by strength(s)

polyethylene glycol 3350 420000 mg / potassium chloride 1480 mg / sodium bicarbonate 5720 mg / sodium chloride 11200 mg powder for oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1522680400NuLytelyNDABraintree Laboratories, Inc.2007-04-17POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEKITNDA01979795586bca-c969-4097-aba6-98f308469e7a

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1105720302NDA AUTHORIZED GENERICAffordable Pharmaceuticals, Llc2013-02-08POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEORALPOWDER, FOR SOLUTIONNDA01979789ca6d56-527a-4be2-baea-531156f0a7be
2105720400NDA AUTHORIZED GENERICAffordable Pharmaceuticals, Llc2013-02-08POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEORALPOWDER, FOR SOLUTIONNDA0197976f0ccd73-bdc9-445e-8b5c-37eefb832903
3400320050ANDANovel Laboratories, Inc.2009-05-28POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEORALPOWDER, FOR SOLUTIONANDA090019444c83ae-ac3a-467c-be05-e2bcbfbaaba1
4433860050GaviLyte-NANDAGavis Pharmaceuticals, Llc2009-05-28POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEORALPOWDER, FOR SOLUTIONANDA09001927195187-75a3-431f-90d9-84da1b94e849
5515256831TriLyteANDAWallace Pharmaceuticals Inc.2013-09-23POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDENASOGASTRICPOWDER, FOR SOLUTIONANDA076491486598b1-0358-11e3-8ffd-0800200c9a66
6643800768ANDAStrides Arcolab Limited2015-04-14POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEORALPOWDER, FOR SOLUTIONANDA20455937c111ec-5b62-42b9-bbb2-3b0c530e34c9
7682200131TriLyteANDAAlaven Pharmaceutical2004-06-24POLYETHYLENE GLYCOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDENASOGASTRICPOWDER, FOR SOLUTIONANDA0764917cc71392-22b1-4234-a0e2-e227824409de

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076491TRILYTEMEDA PHARMACEUTICALS INC2004-02-05ANDA076491_001
2ANDA079232LAX-LYTE WITH FLAVOR PACKSPADDOCK LABORATORIES LLC2010-02-25ANDA079232_001
3ANDA090019PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDENOVEL LABORATORIES INC2009-05-27ANDA090019_001
4ANDA090409PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEMYLAN PHARMACEUTICALS INC2010-04-02ANDA090409_001
5ANDA204559PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDESTRIDES ARCOLAB LTD2015-04-13ANDA204559_001
6NDA019797NULYTELYBRAINTREE LABORATORIES INC1991-04-22NDA019797_001, NDA019797_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076491_001RXSODIUM BICARBONATE (5.72GM/BOT), SODIUM CHLORIDE (11.2GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT), POTASSIUM CHLORIDE (1.48GM/BOT)ORALFOR SOLUTIONFalseAA2004-02-05TRILYTE
2ANDA079232_001RXSODIUM BICARBONATE (5.72GM/BOT), POTASSIUM CHLORIDE (1.48GM/BOT), SODIUM CHLORIDE (11.2GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT)ORALFOR SOLUTIONFalseAA2010-02-25LAX-LYTE WITH FLAVOR PACKS
3ANDA090019_001RXPOTASSIUM CHLORIDE (1.48GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT), SODIUM CHLORIDE (11.2GM/BOT), SODIUM BICARBONATE (5.72GM/BOT)ORALFOR SOLUTIONFalseAA2009-05-27PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
4ANDA090409_001RXSODIUM BICARBONATE (5.72GM/BOT), SODIUM CHLORIDE (11.2GM/BOT), POTASSIUM CHLORIDE (1.48GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT)ORALFOR SOLUTIONFalseAA2010-04-02PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
5ANDA204559_001RXSODIUM CHLORIDE (11.2GM/BOT), SODIUM BICARBONATE (5.72GM/BOT), POTASSIUM CHLORIDE (1.48GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT)ORALFOR SOLUTIONFalseAA2015-04-13PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
6NDA019797_001RXSODIUM CHLORIDE (11.2GM/BOT), SODIUM BICARBONATE (5.72GM/BOT), POTASSIUM CHLORIDE (1.48GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT)ORALFOR SOLUTIONTrueAA1991-04-22NULYTELY
7NDA019797_002RXPOTASSIUM CHLORIDE (1.48GM/BOT), SODIUM CHLORIDE (11.2GM/BOT), SODIUM BICARBONATE (5.72GM/BOT), POLYETHYLENE GLYCOL 3350 (420GM/BOT)ORALFOR SOLUTIONTrueAA1994-11-18NULYTELY

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
127195187-75a3-431f-90d9-84da1b94e849 (view SPL)GaviLyte TM N with Flavor PackprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE, REPACK2009-05-281433860050
237c111ec-5b62-42b9-bbb2-3b0c530e34c9 (view SPL)These highlights do not include all the information needed to use POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for Oral Solution safely and effectively. See full prescribing information for POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for Oral Solution. POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE and POTASSIUM CHLORIDE for Oral Solution (UNFLAVORED, LEMON AND ORANGE FLAVORS) Initial U.S. Approval: 1991prescriptionHuman PrescriptionStrides Arcolab Limitedanalysis, manufacture2015-03-311643800768
3444c83ae-ac3a-467c-be05-e2bcbfbaaba1 (view SPL)PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution with Flavor packprescriptionHuman PrescriptionNovel Laboratories, Inc.API MANUFACTURE, MANUFACTURE, REPACK2009-05-282400320050
4486598b1-0358-11e3-8ffd-0800200c9a66 (view SPL)TriLyte with flavor packsprescriptionHuman PrescriptionWallace Pharmaceuticals Inc.2013-08-161515256831
56f0ccd73-bdc9-445e-8b5c-37eefb832903 (view SPL)These highlights do not include all the information needed to use PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution safely and effectively. See full prescribing information for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution Initial U.S. Approval: 1991prescriptionHuman PrescriptionAffordable Pharmaceuticals, LlcANALYSIS, LABEL, MANUFACTURE2013-09-303105720400
67cc71392-22b1-4234-a0e2-e227824409de (view SPL)TriLyte with flavor packsprescriptionHuman PrescriptionAlaven Pharmaceutical2009-08-272682200131
789ca6d56-527a-4be2-baea-531156f0a7be (view SPL)These highlights do not include all the information needed to use PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution safely and effectively. See full prescribing information for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution Initial U.S. Approval: 1991prescriptionHuman PrescriptionAffordable Pharmaceuticals, LlcANALYSIS, LABEL, MANUFACTURE2013-09-022105720302
895586bca-c969-4097-aba6-98f308469e7a (view SPL)These highlights do not include all the information needed to use NuLYTELY safely and effectively. See full prescribing information for NuLYTELY.NuLYTELY (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution)Initial U.S. Approval: 1991prescriptionHuman PrescriptionBraintree Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-09-303522680400

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII