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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
ndc (product): 63941-489
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
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
application applno (ANDA): 090812
application number: ANDA090812
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
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
application applno (ANDA): 090812
application number: ANDA090812
ndc (product): 79739-7116
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
ndc (product): 57896-489

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 64 matching rows.

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