FDA.reportPublic FDA data

Application 091077

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULNoNo
002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/PACKETNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091077-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06
A091077-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 68788-7508
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 43386-312
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 17856-0312
GAVILAXPOLYETHYLENE GLYCOL 3350A-S Medication Solutions581baa4b-7331-47a3-81c6-680286f03aca2025-01-09WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 50090-5310
GAVILAXPOLYETHYLENE GLYCOL 3350Proficient Rx LP199d6173-3fad-49e4-88fe-bde7223ed4c32022-06-01WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 63187-368
Polyethylene GlycolPOLYETHYLENE GLYCOLBluePoint Laboratoriesc4cae70c-68da-0bbc-e053-2a95a90a395a2021-09-20WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 68001-505

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 · 52 matching rows.

NDC, Name, Nonproprietary name table
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#

Document, Submission type, Date table
DocumentSubmission typeDate
39615ORIG2009-10-21
9317ORIG2009-10-14