Home Applications 090685 Application 090685
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 FOR SOLUTION;ORAL 17GM/PACKET No No 002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 FOR SOLUTION;ORAL 17GM/SCOOPFUL No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090685-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 A090685-002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 782e0a99824c…
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.
NDC Listings For This Application# NDC listings for this application page 2 of 3 · 175 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45802-868 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Perrigo New York Inc ANDA Current 45802-868 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Perrigo New York Inc ANDA Current 45802-868 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Perrigo New York Inc ANDA Current 45802-868 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Perrigo New York Inc ANDA Current 46122-014 Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 Amerisource Bergen ANDA Current 46122-014 Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 Amerisource Bergen ANDA Current 46122-014 Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 Amerisource Bergen ANDA Current 46122-014 Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 Amerisource Bergen ANDA Current 46122-014 Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 Amerisource Bergen ANDA Current 46122-014 Good Neighbor Pharmacy ClearLax Polyethylene Glycol 3350 Amerisource Bergen ANDA Current 49035-306 equate clear lax Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-306 equate clear lax Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-306 equate clear lax Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-306 equate clear lax Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-306 equate clear lax Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49348-893 sunmark clearlax Polyethylene Glycol 3350 McKesson ANDA Current 49348-893 sunmark clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 49348-893 sunmark clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 49348-893 sunmark clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 49348-893 sunmark clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 49348-893 sunmark clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 49738-306 Smart Sense Clearlax Polyethylene Glycol 3350 Kmart Corporation ANDA Current 49738-306 Smart Sense Clearlax Polyethylene Glycol 3350 Kmart Corporation ANDA Current 50090-1447 sunmark clearlax Polyethylene Glycol 3350 A-S Medication Solutions ANDA Current 50090-2430 Polyethylene Glycol 3350 Polyethylene Glycol 3350 A-S Medication Solutions ANDA Current 50090-2430 Polyethylene Glycol 3350 Polyethylene Glycol 3350 A-S Medication Solutions ANDA Current 50594-306 sound body clearlax Polyethylene Glycol 3350 Big Lots Stores, Inc. ANDA Current 50594-306 sound body clearlax Polyethylene Glycol 3350 Big Lots Stores, Inc. ANDA Current 50594-306 sound body clearlax Polyethylene Glycol 3350 Big Lots Stores, Inc. ANDA Current 55301-306 Exchange Select ClearLax Polyethylene Glycol 3350 Army & Air Force Exchange Service ANDA Current 55301-306 Exchange Select ClearLax Polyethylene Glycol 3350 Army & Air Force Exchange Service ANDA Current 55301-306 Exchange Select ClearLax Polyethylene Glycol 3350 Army & Air Force Exchange Service ANDA Current 55316-306 healthy accents clear lax Polyethylene Glycol 3350 DZA Brands LLC ANDA Current 55316-306 healthy accents clear lax Polyethylene Glycol 3350 DZA Brands LLC ANDA Current 55319-306 family wellness laxative Polyethylene Glycol 3350 Family Dollar Services Inc ANDA Current 55319-306 family wellness laxative Polyethylene Glycol 3350 Family Dollar Services Inc ANDA Current 55319-306 family wellness laxative Polyethylene Glycol 3350 Family Dollar Services Inc ANDA Current 55319-306 family wellness laxative Polyethylene Glycol 3350 Family Dollar Services Inc ANDA Current 55910-306 dg health clearlax Polyethylene Glycol 3350 Dolgencorp, LLC ANDA Current 55910-306 dg health clearlax Polyethylene Glycol 3350 Dolgencorp, LLC ANDA Current 55910-306 dg health clearlax Polyethylene Glycol 3350 Dolgencorp, LLC ANDA Current 55910-306 dg health clearlax Polyethylene Glycol 3350 Dolgencorp, LLC ANDA Current 56062-306 clearlax Polyethylene Glycol 3350 Publix Super Markets Inc ANDA Current 56062-306 clearlax Polyethylene Glycol 3350 Publix Super Markets Inc ANDA Current 59779-306 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current 59779-306 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current 59779-306 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current 59779-306 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current 59779-306 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current 59779-306 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current 61715-150 Preferred Plus ClearLax Polyethylene Glycol 3350 Kinray ANDA Current 61715-150 Preferred Plus ClearLax Polyethylene Glycol 3350 Kinray ANDA Current 62011-0153 health mart clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 62011-0153 health mart clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 62011-0153 health mart clearlax Polyethylene Glycol 3350 McKesson ANDA Current 62011-0153 health mart clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 62011-0153 health mart clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 62011-0298 Health Mart Clearlax Polyethylene Glycol 3350 Mckesson ANDA Current 62011-0298 Health Mart Clearlax Polyethylene Glycol 3350 Strategic Sourcing Services LLC ANDA Current 63739-198 SKY PEG3350 Polyethylene Glycol 3350 McKesson Corporation dba SKY Packaging ANDA Current 63739-198 SKY PEG3350 Polyethylene Glycol 3350 McKesson Corporation dba SKY Packaging ANDA Current 63739-198 SKY PEG3350 Polyethylene Glycol 3350 McKesson Corporation dba SKY Packaging ANDA Current 63981-306 kirkland signature laxaclear Polyethylene Glycol 3350 Costco Wholesale Company ANDA Current 63981-306 kirkland signature laxaclear Polyethylene Glycol 3350 Costco Wholesale Company ANDA Current 63981-306 kirkland signature laxaclear Polyethylene Glycol 3350 Costco Wholesale Company ANDA Current 63981-306 kirkland signature laxaclear Polyethylene Glycol 3350 Costco Wholesale Company ANDA Current 64024-306 Welby ClearLax Polyethylene Glycol 3350 Aldi, Inc ANDA Current 64024-306 Welby ClearLax Polyethylene Glycol 3350 Aldi, Inc ANDA Current 64024-306 Welby ClearLax Polyethylene Glycol 3350 Aldi, Inc ANDA Current 64024-306 Welby ClearLax Polyethylene Glycol 3350 Aldi, Inc ANDA Current 68196-306 Members Mark clearlax Polyethylene Glycol 3350 Sam's West Inc ANDA Current 68196-306 Members Mark clearlax Polyethylene Glycol 3350 Sam's West Inc ANDA Current 68196-306 Members Mark clearlax Polyethylene Glycol 3350 Sam's West Inc ANDA Current 68391-306 berkley and jensen clearlax Polyethylene Glycol 3350 BJWC ANDA Current 68391-306 berkley and jensen clearlax Polyethylene Glycol 3350 BJWC ANDA Current 68391-306 berkley and jensen clearlax Polyethylene Glycol 3350 BJWC ANDA Current 69256-306 harris teeter clearlax Polyethylene Glycol 3350 Harris Teeter, LLC ANDA Current 69256-306 harris teeter clearlax Polyethylene Glycol 3350 Harris Teeter, LLC ANDA Current 69256-306 harris teeter clearlax Polyethylene Glycol 3350 Harris Teeter, LLC ANDA Current 69842-458 purelax Polyethylene Glycol 3350 CVS Pharmacy ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31486 ORIG 2009-10-14