FDA.reportPublic FDA data

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 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
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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06e64feba35796…
2022-09-29 23:25 UTC2022-09A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090685-001POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090685-002POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a50c72e98297…

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 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 30142-306
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
clear laxPOLYETHYLENE GLYCOL 3350HyVee Inc5bcf01d8-ddf3-4e64-8d3f-3526a51a58592026-07-02WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 42507-306
CLEARLAXPOLYETHYLENE GLYCOL 3350Safewaya70f41d0-0fad-4d15-8844-d60eabeb67322026-07-02WarningsExact 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
ndc (product): 0363-0306
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 41250-306
equate clear laxPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc56a507f3-0cd1-4f02-9dfd-de297ba4bc1f2026-03-27WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
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
ndc (product): 36800-306
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
LaxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation457f5d2d-4595-482a-9ffa-659fb5d5b1342025-10-09WarningsExact identifier
application applno (ANDA): 090685
application number: ANDA090685
ndc (product): 11822-0306
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

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 3 · 175 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0306Good Sense Clear LaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-0306Good Sense Clear LaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-0306Good Sense Clear LaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-0306Good Sense Clear LaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-1023good sense clearlaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-6900injoy constipation reliefPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-7306Basic Care ClearlaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-7306Basic Care ClearlaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-7306Basic Care ClearlaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0113-7306Basic Care ClearlaxPolyethylene Glycol 3350L. Perrigo CompanyANDACurrent
0363-0306smooth laxPolyethylene Glycol 3350Walgreen CompanyANDACurrent
0363-0306smooth laxPolyethylene Glycol 3350Walgreen CompanyANDACurrent
0363-0306smooth laxPolyethylene Glycol 3350Walgreen CompanyANDACurrent
0363-0306smooth laxPolyethylene Glycol 3350Walgreen CompanyANDACurrent
0363-0306smooth laxPolyethylene Glycol 3350Walgreen CompanyANDACurrent
0363-0306smooth laxPolyethylene Glycol 3350Walgreen CompanyANDACurrent
0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350Rugby LaboratoriesANDACurrent
0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350Rugby LaboratoriesANDACurrent
0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350Rugby LaboratoriesANDACurrent
0536-1052rugby PEG 3350POLYETHYLENE GLYCOL 3350Rugby LaboratoriesANDACurrent
0904-6025peg 3350Polyethylene Glycol 3350Major PharmaceuticalsANDACurrent
0904-6025peg 3350Polyethylene Glycol 3350Major PharmaceuticalsANDACurrent
0904-6422PEG 3350POLYETHYLENE GLYCOL 3350Major PharmaceuticalsANDACurrent
0904-6422PEG 3350POLYETHYLENE GLYCOL 3350Major PharmaceuticalsANDACurrent
0904-6422PEG 3350POLYETHYLENE GLYCOL 3350Major PharmaceuticalsANDACurrent
0904-6422PEG 3350POLYETHYLENE GLYCOL 3350Major PharmaceuticalsANDACurrent
11673-306up and up powderlaxPolyethylene Glycol 3350Target CorporationANDACurrent
11673-306up and up powderlaxPolyethylene Glycol 3350Target CorporationANDACurrent
11673-306up and up powderlaxPolyethylene Glycol 3350Target CorporationANDACurrent
11673-306up and up powderlaxPolyethylene Glycol 3350Target CorporationANDACurrent
11673-306up and up powderlaxPolyethylene Glycol 3350Target CorporationANDACurrent
11822-0306LaxativePolyethylene Glycol 3350Rite Aid CorporationANDACurrent
11822-0306LaxativePolyethylene Glycol 3350Rite Aid CorporationANDACurrent
11822-0306LaxativePolyethylene Glycol 3350Rite Aid CorporationANDACurrent
11822-0306LaxativePolyethylene Glycol 3350Rite Aid CorporationANDACurrent
11822-0306LaxativePolyethylene Glycol 3350Rite Aid CorporationANDACurrent
11822-0306LaxativePolyethylene Glycol 3350Rite Aid CorporationANDACurrent
21130-847signature care clearlaxPolyethylene Glycol 3350SafewayANDACurrent
21130-847signature care clearlaxPolyethylene Glycol 3350SafewayANDACurrent
21130-847signature care clearlaxPolyethylene Glycol 3350SafewayANDACurrent
21130-847signature care clearlaxPolyethylene Glycol 3350SafewayANDACurrent
21695-566Clearlaxpolyethylene glycolRebel Distributors CorpANDACurrent
30142-306gentle laxPolyethylene Glycol 3350Kroger CompanyANDACurrent
30142-306gentle laxPolyethylene Glycol 3350Kroger CompanyANDACurrent
30142-306gentle laxPolyethylene Glycol 3350Kroger CompanyANDACurrent
30142-306gentle laxPolyethylene Glycol 3350Kroger CompanyANDACurrent
30142-306gentle laxPolyethylene Glycol 3350Kroger CompanyANDACurrent
30142-306gentle laxPolyethylene Glycol 3350Kroger CompanyANDACurrent
36800-306Topcare ClearLaxPolyethylene Glycol 3350Topco Associates LLCANDACurrent
36800-306Topcare ClearLaxPolyethylene Glycol 3350Topco Associates LLCANDACurrent
36800-306Topcare ClearLaxPolyethylene Glycol 3350Topco Associates LLCANDACurrent
36800-306Topcare ClearLaxPolyethylene Glycol 3350Topco Associates LLCANDACurrent
36800-306Topcare ClearLaxPolyethylene Glycol 3350Topco Associates LLCANDACurrent
37012-306clearlaxPolyethylene Glycol 3350Shopko Stores Operating Co., LLCANDACurrent
37012-306clearlaxPolyethylene Glycol 3350Shopko Stores Operating Co., LLCANDACurrent
37205-612Leader Clear LaxPolyethylene Glycol 3350Cardinal HealthANDACurrent
37205-612Leader Clear LaxPolyethylene Glycol 3350Cardinal HealthANDACurrent
37205-612Leader Clear LaxPolyethylene Glycol 3350Cardinal HealthANDACurrent
37808-306clear laxPolyethylene Glycol 3350H E BANDACurrent
37808-306clear laxPolyethylene Glycol 3350H E BANDACurrent
37808-306clear laxPolyethylene Glycol 3350H E BANDACurrent
41163-306equaline clearlaxPolyethylene Glycol 3350Supervalu IncANDACurrent
41163-306equaline clearlaxPolyethylene Glycol 3350Supervalu IncANDACurrent
41163-306equaline clearlaxPolyethylene Glycol 3350Supervalu IncANDACurrent
41163-306equaline clearlaxPolyethylene Glycol 3350Supervalu IncANDACurrent
41163-306equaline clearlaxPolyethylene Glycol 3350Supervalu IncANDACurrent
41190-306ShopRite Clear LaxativePolyethylene Glycol 3350Wakefern Food CorporationANDACurrent
41190-306ShopRite Clear LaxativePolyethylene Glycol 3350Wakefern Food CorporationANDACurrent
41250-306clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41250-306clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41250-306clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41250-306clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41250-306clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41250-939clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41250-939clear laxPolyethylene Glycol 3350Meijer Distribution IncANDACurrent
41520-306care one clearlaxPolyethylene Glycol 3350American Sales CompanyANDACurrent
41520-306care one clearlaxPolyethylene Glycol 3350American Sales CompanyANDACurrent
41520-306care one clearlaxPolyethylene Glycol 3350American Sales CompanyANDACurrent
41520-306care one clearlaxPolyethylene Glycol 3350American Sales CompanyANDACurrent
42507-306clear laxPolyethylene Glycol 3350HyVee IncANDACurrent

Documents#

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