FDA.reportPublic FDA data

Application 090812

Type
ANDA
Sponsor
NEXGEN PHARMA

Application Products#

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

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