FDA.reportPublic FDA data

Application 077706

Type
ANDA
Sponsor
NEXGEN PHARMA INC

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 43.

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
A077706-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-2784e616aacf4f…
2026-08-18 06:07:402026-07A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-273f01610625f2…
2019-09-15 20:21 UTC2019-09A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077706-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2006-09-27f41ea6bd6efb…

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 3 of 5 · 94 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
WalgreensPOLYETHYLENE GLYCOL 3350WALGREEN COMPANY97489a02-db59-4529-a091-abc737e44a962025-12-01WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsName fallback
brand name: Polyethylene Glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLCe26457c4-03e8-430e-bfad-38ae105dbf6f2025-10-23WarningsName fallback
brand name: Polyethylene glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC2f5c975f-0d35-4f68-a27c-28af9a8987332025-10-23WarningsName fallback
brand name: Polyethylene glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
MiraLAXPOLYETHYLENE GLYCOL 3350ASCLEMED USA INC.e652042f-3707-4bf6-831d-d806638b7d852025-10-14WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack5df518fb-ad58-4f17-af34-f66066f1313a2025-09-30WarningsName fallback
brand name: Polyethylene Glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
DulcolaxPOLYETHYLENE GLYCOL 3350Chattem, Inc.ed16d0f4-74e7-4fa3-989d-c6840a5d3e712025-09-30WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsName fallback
brand name: Polyethylene Glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350SKY Packaging173a62cb-9b20-4b50-e063-6294a90ac36b2025-05-14WarningsName fallback
brand name: Polyethylene Glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsName fallback
brand name: Polyethylene Glycol 3350
generic name: POLYETHYLENE GLYCOL 3350
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0722-6920Polyethylene Glycol 3350Polyethylene Glycol 3350Nexgen Pharma, Inc.ANDACurrent
0722-6921Polyethylene Glycol 3350Polyethylene Glycol 3350Nexgen Pharma, Inc.ANDACurrent
17856-0457Polyethylene Glycol 3350Polyethylene Glycol 3350Atlantic Biologicals CorpsANDACurrent
35356-544Polyethylene Glycol 3350Polyethylene Glycol 3350Lake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
51991-457Polyethylene Glycol 3350Polyethylene Glycol 3350Breckenridge Pharmaceutical, Inc.ANDACurrent
68071-1316Polyethylene Glycol 3350Polyethylene Glycol 3350NuCare Pharmaceuticals,Inc.ANDACurrent
68071-1316Polyethylene Glycol 3350Polyethylene Glycol 3350NuCare Pharmaceuticals,Inc.ANDACurrent
68071-1316Polyethylene Glycol 3350Polyethylene Glycol 3350NuCare Pharmaceuticals,Inc.ANDACurrent
71205-011Polyethylene Glycol 3350Polyethylene Glycol 3350Proficient Rx LPANDACurrent
71205-011Polyethylene Glycol 3350Polyethylene Glycol 3350Proficient Rx LPANDACurrent