FDA.report

Application 091077

Type
ANDA
Sponsor
NOVEL LABS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULNoNo
002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/PACKETNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0536-1052PEG 3350POLYETHYLENE GLYCOL 3350Rugby LaboratoriesANDACurrent
17856-0312GAVILAXPolyethylene Glycol 3350Atlantic Biologicals CorpsANDACurrent
17856-0312GAVILAXPolyethylene Glycol 3350ATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0312GAVILAXPolyethylene Glycol 3350Atlantic Biologicals CorpsANDACurrent
40032-312Polyethylene Glycol-3350Polyethylene Glycol-3350Novel Laboratories, Inc.ANDACurrent
43386-312GAVILAXPolyethylene Glycol 3350Lupin Pharmaceuticals,Inc.ANDACurrent
43386-312GAVILAXPolyethylene Glycol 3350Lupin Pharmaceuticals,Inc.ANDACurrent
43386-312GAVILAXPolyethylene Glycol 3350Lupin Pharmaceuticals,Inc.ANDACurrent
49035-316ClearLaxpolyethylene glycol 3350Wal-Mart Stores, Inc.ANDACurrent
50090-2526PEG 3350POLYETHYLENE GLYCOL 3350A-S Medication SolutionsANDACurrent
50090-5310GAVILAXPolyethylene Glycol 3350A-S Medication SolutionsANDACurrent
50090-5310GAVILAXPolyethylene Glycol 3350A-S Medication SolutionsANDACurrent
55154-6899PEG 3350POLYETHYLENE GLYCOL 3350Cardinal HealthANDACurrent
55154-6899PEG 3350POLYETHYLENE GLYCOL 3350Cardinal HealthANDACurrent
55154-6899PEG 3350POLYETHYLENE GLYCOL 3350Cardinal HealthANDACurrent
55154-7982PEG 3350POLYETHYLENE GLYCOL 3350Cardinal HealthANDACurrent
55154-7982PEG 3350POLYETHYLENE GLYCOL 3350Cardinal HealthANDACurrent
55154-7982PEG 3350POLYETHYLENE GLYCOL 3350Cardinal HealthANDACurrent
61919-542GAVILAXGAVILAXDirectRXANDACurrent
61919-542GAVILAXGAVILAXDirectRXANDACurrent
61919-542GAVILAXGAVILAXDirectRXANDACurrent
63187-368GAVILAXPolyethylene Glycol 3350Proficient Rx LPANDACurrent
63187-368GAVILAXPolyethylene Glycol 3350Proficient Rx LPANDACurrent
63187-368GAVILAXPolyethylene Glycol 3350Proficient Rx LPANDACurrent
63187-368GAVILAXPolyethylene Glycol 3350Proficient Rx LPANDACurrent
63187-368GAVILAXPolyethylene Glycol 3350Proficient Rx LPANDACurrent
63187-368GAVILAXPolyethylene Glycol 3350Proficient Rx LPANDACurrent
63941-332EasyLaxPolyethylene GlycolBest Choice (Valu Merchandisers Company)ANDACurrent
63941-332EasyLaxPolyethylene GlycolBest Choice (Valu Merchandisers Company)ANDACurrent
67091-306EasyLAXPolyethylene GlycolWinCo Foods, LLCANDACurrent
67091-306EasyLAXPolyethylene GlycolWinCo Foods, LLCANDACurrent
68001-505Polyethylene GlycolPolyethylene GlycolBluePoint LaboratoriesANDACurrent
68001-505Polyethylene GlycolPolyethylene GlycolBluePoint LaboratoriesANDACurrent
68001-505Polyethylene GlycolPolyethylene GlycolBluePoint LaboratoriesANDACurrent
68788-7508GAVILAXPolyethylene Glycol 3350Preferred Pharmaceuticals, Inc.ANDACurrent
68788-7508GAVILAXPolyethylene Glycol 3350Preferred Pharmaceuticals, Inc.ANDACurrent
68788-7508GAVILAXPolyethylene Glycol 3350Preferred Pharmaceuticals, Inc.ANDACurrent
68788-7508GAVILAXPolyethylene Glycol 3350Preferred Pharmaceuticals, Inc.ANDACurrent
68788-9849GAVILAXPolyethylene Glycol 3350Preferred Pharmaceuticals, Inc.ANDACurrent
68788-9849GAVILAXPolyethylene Glycol 3350Preferred Pharmaceuticals, Inc.ANDACurrent
68998-465EasyLAXPolyethylene GlycolMarc Glassman, Inc.ANDACurrent
68998-465EasyLAXPolyethylene GlycolMarc Glassman, Inc.ANDACurrent
71141-140Osmotic LaxativePolyethylene GlycolLidl US, LLCANDACurrent
71141-140Osmotic LaxativePolyethylene GlycolLidl US, LLCANDACurrent
71141-140Osmotic LaxativePolyethylene GlycolLidl US, LLCANDACurrent
76470-005EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent
76470-005EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent
76470-005EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent
76470-006EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent
76470-006EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent
76470-020EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent
76470-020EZ2goPOLYETHYLENE GLYCOL 3350Valley Medical Products,LLCANDACurrent

Documents

DocumentSubmission typeDate
39615ORIG2009-10-21
9317ORIG2009-10-14