Application 090812

Type
ANDA
Sponsor
NEXGEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090812-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVEPharmaceutica North America, Inc.d048111f-8144-4d51-a0c2-a967b2bce4552025-03-04WarningsExact identifier
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsExact identifier
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVELGM PHARMA SOLUTIONS, LLCd78bead5-ff19-4d45-9003-ec131f1f5a132024-01-17WarningsExact identifier
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose , get medical help or contact a Poison Control Center right away.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0224-1890Mighty LaxPOLYETHYLENE GLYCOL 3350Konsyl Pharmaceuticals, Inc.ANDACurrent
0224-1890Mighty LaxPOLYETHYLENE GLYCOL 3350Konsyl Pharmaceuticals, Inc.ANDACurrent
0363-0489Smooth LAXpolyethylene glycol 3350WALGREENSANDACurrent
0363-0489Smooth LAXpolyethylene glycol 3350WALGREENSANDACurrent
0363-0489Smooth LAXpolyethylene glycol 3350WALGREENSANDACurrent
0722-7116Polyethylene Glycol 3350, NF Powder for Solution, LaxativePolyethylene Glycol 3350, NF Powder for Solution, LaxativeNexgen Pharma, Inc.ANDACurrent
0722-7116Polyethylene Glycol 3350, NF Powder for Solution, LaxativePolyethylene Glycol 3350, NF Powder for Solution, LaxativeNexgen Pharma, Inc.ANDACurrent
17856-0489POLYETHYLENE GLYCOL 3350polyethylene glycol 3350ATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0962Polyethylene Glycol 3350polyethylene glycol 3350ATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0962Polyethylene Glycol 3350polyethylene glycol 3350ATLANTIC BIOLOGICALS CORP.ANDACurrent
21695-598Polyethylene Glycol 3350, NF Powder for Solution, LaxativePolyethylene Glycol 3350, NF Powder for Solution, LaxativeRebel Distributors CorpANDACurrent
49348-143CLEARLAXpolyethylene glycol 3350MCKESSON (SUNMARK)ANDACurrent
49348-143CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
49348-143CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
49348-143CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
49348-143CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
51991-961Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-961Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-961Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-961Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-961Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-962Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-962Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-962Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-962Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
51991-962Polyethylene Glycol 3350polyethylene glycol 3350Breeckenridge Pharmaceutical, Inc.ANDACurrent
53943-742Polyethylene glycol 3350Polyethylene glycol 3350Discount Drug MartANDACurrent
53943-742Polyethylene glycol 3350Polyethylene glycol 3350Discount Drug MartANDACurrent
53943-742Polyethylene glycol 3350Polyethylene glycol 3350Discount Drug MartANDACurrent
53943-742Polyethylene glycol 3350Polyethylene glycol 3350Discount Drug MartANDACurrent
53943-742Polyethylene glycol 3350Polyethylene glycol 3350Discount Drug MartANDACurrent
55154-7136healthylaxPolyethylene Glycol 3350Cardinal HealthANDACurrent
55154-7136healthylaxPolyethylene Glycol 3350Cardinal HealthANDACurrent
55315-369LAXATIVEpolyethylene glycol 3350FRED'S INC.ANDACurrent
55315-369LAXATIVEpolyethylene glycol 3350FRED'S INC.ANDACurrent
57896-489POLYETHYLENE GLYCOL 3350polyethylene glycol 3350Geri-Care Pharmaceutical CorpANDACurrent
57896-489POLYETHYLENE GLYCOL 3350polyethylene glycol 3350Geri-Care Pharmaceutical CorpANDACurrent
57896-489POLYETHYLENE GLYCOL 3350polyethylene glycol 3350Geri-Care Pharmaceutical CorpANDACurrent
57896-489POLYETHYLENE GLYCOL 3350polyethylene glycol 3350Geri-Care Pharmaceutical CorpANDACurrent
61919-879POLYTHYLENE GLYCOLPOLYTHYLENE GLYCOLDIRECT RXANDACurrent
62011-0287CLEARLAXpolyethylene glycol 3350MCKESSONANDACurrent
62011-0287CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
62011-0287CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
62011-0287CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
62011-0287CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
62011-0287CLEARLAXpolyethylene glycol 3350STRATEGIC SOURCING SERVICES LLCANDACurrent
63629-2061Polyethylene Glycol 3350polyethylene glycol 3350Bryant Ranch PrepackANDACurrent
63629-8541Polyethylene Glycol 3350polyethylene glycol 3350Bryant Ranch PrepackANDACurrent
63629-8541Polyethylene Glycol 3350polyethylene glycol 3350Bryant Ranch PrepackANDACurrent
63868-002NATURA-LAXpolyethylene glycol 3350Chain Drug Marketing AssociationANDACurrent
63868-002NATURA-LAXpolyethylene glycol 3350Chain Drug Marketing AssociationANDACurrent
63868-002NATURA-LAXpolyethylene glycol 3350Chain Drug Marketing AssociationANDACurrent
63941-489EasyLAXpolyethylene glycol 3350VALU MERCHANDISERS COMPANYANDACurrent
63941-489EasyLAXpolyethylene glycol 3350VALU MERCHANDISERS COMPANYANDACurrent
63941-489EasyLAXpolyethylene glycol 3350VALU MERCHANDISERS COMPANYANDACurrent
63941-489EasyLAXpolyethylene glycol 3350VALU MERCHANDISERS COMPANYANDACurrent
68016-726Laxativepolyethylene glycol 3350Chain Drug Consortium, LLCANDACurrent
68016-726Laxativepolyethylene glycol 3350Chain Drug Consortium, LLCANDACurrent
68016-726Laxativepolyethylene glycol 3350Chain Drug Consortium, LLCANDACurrent
68016-726Laxativepolyethylene glycol 3350Chain Drug Consortium, LLCANDACurrent
68084-430healthylaxPolyethylene Glycol 3350American Health PackagingANDACurrent
68084-430healthylaxPolyethylene Glycol 3350American Health PackagingANDACurrent
79739-7116Polyethylene Glycol 3350, NF Powder for Solution, LaxativePolyethylene Glycol 3350, NF Powder for Solution, LaxativeLGM PHARMA SOLUTIONS, LLCANDACurrent
79739-7116Polyethylene Glycol 3350, NF Powder for Solution, LaxativePolyethylene Glycol 3350, NF Powder for Solution, LaxativeLGM Pharma Solutions, LLCANDACurrent