Application 090685

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090685-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06
A090685-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06782e0a99824c…

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 3 · 51 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clear laxPOLYETHYLENE GLYCOL 3350HyVee Inc5bcf01d8-ddf3-4e64-8d3f-3526a51a58592026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
CLEARLAXPOLYETHYLENE GLYCOL 3350Safewaya70f41d0-0fad-4d15-8844-d60eabeb67322026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
equate clear laxPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc56a507f3-0cd1-4f02-9dfd-de297ba4bc1f2026-03-27WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 49035-306
foster and thrive clearlaxPOLYETHYLENE GLYCOL 3350Strategic Sourcing Services LLC684e35cc-5a4f-458d-b5e7-e1933fea11392026-03-07WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.935f05da-3637-4a9e-843e-1f2ced5d1a742026-01-23WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
MiraLAX Orange FlavorPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.0a5b2121-928f-8f49-e063-6394a90a8aaf2025-12-04WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350A-S Medication Solutions4f31a33e-1f60-4aa7-b1dc-a3c011c03a702025-10-29WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 50090-2430
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack5df518fb-ad58-4f17-af34-f66066f1313a2025-09-30WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
DulcolaxPOLYETHYLENE GLYCOL 3350Chattem, Inc.ed16d0f4-74e7-4fa3-989d-c6840a5d3e712025-09-30WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
kirkland signature laxaclear original prescription strengthPOLYETHYLENE GLYCOL 3350Costco Wholesale Companyf58fa5c0-8ab7-4427-aea0-d536b47acbb52025-09-18WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 63981-306
up and up powderlaxPOLYETHYLENE GLYCOL 3350Target Corporation1bceb457-b24f-485d-bfe2-af4b7d38a5c22025-09-18WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2025-03-21WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 59779-306
clear laxPOLYETHYLENE GLYCOL 3350H E Bbd16827b-5e6a-4fa7-bc2e-c9a05e1e2dab2024-12-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 175 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-868Polyethylene Glycol 3350Polyethylene Glycol 3350Perrigo New York IncANDACurrent
45802-868Polyethylene Glycol 3350Polyethylene Glycol 3350Perrigo New York IncANDACurrent
45802-868Polyethylene Glycol 3350Polyethylene Glycol 3350Perrigo New York IncANDACurrent
45802-868Polyethylene Glycol 3350Polyethylene Glycol 3350Perrigo New York IncANDACurrent
46122-014Good Neighbor Pharmacy ClearLaxPolyethylene Glycol 3350Amerisource BergenANDACurrent
46122-014Good Neighbor Pharmacy ClearLaxPolyethylene Glycol 3350Amerisource BergenANDACurrent
46122-014Good Neighbor Pharmacy ClearLaxPolyethylene Glycol 3350Amerisource BergenANDACurrent
46122-014Good Neighbor Pharmacy ClearLaxPolyethylene Glycol 3350Amerisource BergenANDACurrent
46122-014Good Neighbor Pharmacy ClearLaxPolyethylene Glycol 3350Amerisource BergenANDACurrent
46122-014Good Neighbor Pharmacy ClearLaxPolyethylene Glycol 3350Amerisource BergenANDACurrent
49035-306equate clear laxPolyethylene Glycol 3350Wal-Mart Stores IncANDACurrent
49035-306equate clear laxPolyethylene Glycol 3350Wal-Mart Stores IncANDACurrent
49035-306equate clear laxPolyethylene Glycol 3350Wal-Mart Stores IncANDACurrent
49035-306equate clear laxPolyethylene Glycol 3350Wal-Mart Stores IncANDACurrent
49035-306equate clear laxPolyethylene Glycol 3350Wal-Mart Stores IncANDACurrent
49348-893sunmark clearlaxPolyethylene Glycol 3350McKessonANDACurrent
49348-893sunmark clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
49348-893sunmark clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
49348-893sunmark clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
49348-893sunmark clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
49348-893sunmark clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
49738-306Smart Sense ClearlaxPolyethylene Glycol 3350Kmart CorporationANDACurrent
49738-306Smart Sense ClearlaxPolyethylene Glycol 3350Kmart CorporationANDACurrent
50090-1447sunmark clearlaxPolyethylene Glycol 3350A-S Medication SolutionsANDACurrent
50090-2430Polyethylene Glycol 3350Polyethylene Glycol 3350A-S Medication SolutionsANDACurrent
50090-2430Polyethylene Glycol 3350Polyethylene Glycol 3350A-S Medication SolutionsANDACurrent
50594-306sound body clearlaxPolyethylene Glycol 3350Big Lots Stores, Inc.ANDACurrent
50594-306sound body clearlaxPolyethylene Glycol 3350Big Lots Stores, Inc.ANDACurrent
50594-306sound body clearlaxPolyethylene Glycol 3350Big Lots Stores, Inc.ANDACurrent
55301-306Exchange Select ClearLaxPolyethylene Glycol 3350Army & Air Force Exchange ServiceANDACurrent
55301-306Exchange Select ClearLaxPolyethylene Glycol 3350Army & Air Force Exchange ServiceANDACurrent
55301-306Exchange Select ClearLaxPolyethylene Glycol 3350Army & Air Force Exchange ServiceANDACurrent
55316-306healthy accents clear laxPolyethylene Glycol 3350DZA Brands LLCANDACurrent
55316-306healthy accents clear laxPolyethylene Glycol 3350DZA Brands LLCANDACurrent
55319-306family wellness laxativePolyethylene Glycol 3350Family Dollar Services IncANDACurrent
55319-306family wellness laxativePolyethylene Glycol 3350Family Dollar Services IncANDACurrent
55319-306family wellness laxativePolyethylene Glycol 3350Family Dollar Services IncANDACurrent
55319-306family wellness laxativePolyethylene Glycol 3350Family Dollar Services IncANDACurrent
55910-306dg health clearlaxPolyethylene Glycol 3350Dolgencorp, LLCANDACurrent
55910-306dg health clearlaxPolyethylene Glycol 3350Dolgencorp, LLCANDACurrent
55910-306dg health clearlaxPolyethylene Glycol 3350Dolgencorp, LLCANDACurrent
55910-306dg health clearlaxPolyethylene Glycol 3350Dolgencorp, LLCANDACurrent
56062-306clearlaxPolyethylene Glycol 3350Publix Super Markets IncANDACurrent
56062-306clearlaxPolyethylene Glycol 3350Publix Super Markets IncANDACurrent
59779-306purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent
59779-306purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent
59779-306purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent
59779-306purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent
59779-306purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent
59779-306purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent
61715-150Preferred Plus ClearLaxPolyethylene Glycol 3350KinrayANDACurrent
61715-150Preferred Plus ClearLaxPolyethylene Glycol 3350KinrayANDACurrent
62011-0153health mart clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
62011-0153health mart clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
62011-0153health mart clearlaxPolyethylene Glycol 3350McKessonANDACurrent
62011-0153health mart clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
62011-0153health mart clearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
62011-0298Health Mart ClearlaxPolyethylene Glycol 3350MckessonANDACurrent
62011-0298Health Mart ClearlaxPolyethylene Glycol 3350Strategic Sourcing Services LLCANDACurrent
63739-198SKY PEG3350Polyethylene Glycol 3350McKesson Corporation dba SKY PackagingANDACurrent
63739-198SKY PEG3350Polyethylene Glycol 3350McKesson Corporation dba SKY PackagingANDACurrent
63739-198SKY PEG3350Polyethylene Glycol 3350McKesson Corporation dba SKY PackagingANDACurrent
63981-306kirkland signature laxaclearPolyethylene Glycol 3350Costco Wholesale CompanyANDACurrent
63981-306kirkland signature laxaclearPolyethylene Glycol 3350Costco Wholesale CompanyANDACurrent
63981-306kirkland signature laxaclearPolyethylene Glycol 3350Costco Wholesale CompanyANDACurrent
63981-306kirkland signature laxaclearPolyethylene Glycol 3350Costco Wholesale CompanyANDACurrent
64024-306Welby ClearLaxPolyethylene Glycol 3350Aldi, IncANDACurrent
64024-306Welby ClearLaxPolyethylene Glycol 3350Aldi, IncANDACurrent
64024-306Welby ClearLaxPolyethylene Glycol 3350Aldi, IncANDACurrent
64024-306Welby ClearLaxPolyethylene Glycol 3350Aldi, IncANDACurrent
68196-306Members Mark clearlaxPolyethylene Glycol 3350Sam's West IncANDACurrent
68196-306Members Mark clearlaxPolyethylene Glycol 3350Sam's West IncANDACurrent
68196-306Members Mark clearlaxPolyethylene Glycol 3350Sam's West IncANDACurrent
68391-306berkley and jensen clearlaxPolyethylene Glycol 3350BJWCANDACurrent
68391-306berkley and jensen clearlaxPolyethylene Glycol 3350BJWCANDACurrent
68391-306berkley and jensen clearlaxPolyethylene Glycol 3350BJWCANDACurrent
69256-306harris teeter clearlaxPolyethylene Glycol 3350Harris Teeter, LLCANDACurrent
69256-306harris teeter clearlaxPolyethylene Glycol 3350Harris Teeter, LLCANDACurrent
69256-306harris teeter clearlaxPolyethylene Glycol 3350Harris Teeter, LLCANDACurrent
69842-458purelaxPolyethylene Glycol 3350CVS PharmacyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31486ORIG2009-10-14