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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090685-001 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090685-002 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06 caaa826d4ba7…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…
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 3 · 48 matching rows.
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 NDC Name Nonproprietary name Labeler Marketing category Status 0113-0306 Good Sense Clear Lax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-0306 Good Sense Clear Lax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-0306 Good Sense Clear Lax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-0306 Good Sense Clear Lax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-1023 good sense clearlax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-6900 injoy constipation relief Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-7306 Basic Care Clearlax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-7306 Basic Care Clearlax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-7306 Basic Care Clearlax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0113-7306 Basic Care Clearlax Polyethylene Glycol 3350 L. Perrigo Company ANDA Current 0363-0306 smooth lax Polyethylene Glycol 3350 Walgreen Company ANDA Current 0363-0306 smooth lax Polyethylene Glycol 3350 Walgreen Company ANDA Current 0363-0306 smooth lax Polyethylene Glycol 3350 Walgreen Company ANDA Current 0363-0306 smooth lax Polyethylene Glycol 3350 Walgreen Company ANDA Current 0363-0306 smooth lax Polyethylene Glycol 3350 Walgreen Company ANDA Current 0363-0306 smooth lax Polyethylene Glycol 3350 Walgreen Company ANDA Current 0536-1052 rugby PEG 3350 POLYETHYLENE GLYCOL 3350 Rugby Laboratories ANDA Current 0536-1052 rugby PEG 3350 POLYETHYLENE GLYCOL 3350 Rugby Laboratories ANDA Current 0536-1052 rugby PEG 3350 POLYETHYLENE GLYCOL 3350 Rugby Laboratories ANDA Current 0536-1052 rugby PEG 3350 POLYETHYLENE GLYCOL 3350 Rugby Laboratories ANDA Current 0904-6025 peg 3350 Polyethylene Glycol 3350 Major Pharmaceuticals ANDA Current 0904-6025 peg 3350 Polyethylene Glycol 3350 Major Pharmaceuticals ANDA Current 0904-6422 PEG 3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals ANDA Current 0904-6422 PEG 3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals ANDA Current 0904-6422 PEG 3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals ANDA Current 0904-6422 PEG 3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals ANDA Current 11673-306 up and up powderlax Polyethylene Glycol 3350 Target Corporation ANDA Current 11673-306 up and up powderlax Polyethylene Glycol 3350 Target Corporation ANDA Current 11673-306 up and up powderlax Polyethylene Glycol 3350 Target Corporation ANDA Current 11673-306 up and up powderlax Polyethylene Glycol 3350 Target Corporation ANDA Current 11673-306 up and up powderlax Polyethylene Glycol 3350 Target Corporation ANDA Current 11822-0306 Laxative Polyethylene Glycol 3350 Rite Aid Corporation ANDA Current 11822-0306 Laxative Polyethylene Glycol 3350 Rite Aid Corporation ANDA Current 11822-0306 Laxative Polyethylene Glycol 3350 Rite Aid Corporation ANDA Current 11822-0306 Laxative Polyethylene Glycol 3350 Rite Aid Corporation ANDA Current 11822-0306 Laxative Polyethylene Glycol 3350 Rite Aid Corporation ANDA Current 11822-0306 Laxative Polyethylene Glycol 3350 Rite Aid Corporation ANDA Current 21130-847 signature care clearlax Polyethylene Glycol 3350 Safeway ANDA Current 21130-847 signature care clearlax Polyethylene Glycol 3350 Safeway ANDA Current 21130-847 signature care clearlax Polyethylene Glycol 3350 Safeway ANDA Current 21130-847 signature care clearlax Polyethylene Glycol 3350 Safeway ANDA Current 21695-566 Clearlax polyethylene glycol Rebel Distributors Corp ANDA Current 30142-306 gentle lax Polyethylene Glycol 3350 Kroger Company ANDA Current 30142-306 gentle lax Polyethylene Glycol 3350 Kroger Company ANDA Current 30142-306 gentle lax Polyethylene Glycol 3350 Kroger Company ANDA Current 30142-306 gentle lax Polyethylene Glycol 3350 Kroger Company ANDA Current 30142-306 gentle lax Polyethylene Glycol 3350 Kroger Company ANDA Current 30142-306 gentle lax Polyethylene Glycol 3350 Kroger Company ANDA Current 36800-306 Topcare ClearLax Polyethylene Glycol 3350 Topco Associates LLC ANDA Current 36800-306 Topcare ClearLax Polyethylene Glycol 3350 Topco Associates LLC ANDA Current 36800-306 Topcare ClearLax Polyethylene Glycol 3350 Topco Associates LLC ANDA Current 36800-306 Topcare ClearLax Polyethylene Glycol 3350 Topco Associates LLC ANDA Current 36800-306 Topcare ClearLax Polyethylene Glycol 3350 Topco Associates LLC ANDA Current 37012-306 clearlax Polyethylene Glycol 3350 Shopko Stores Operating Co., LLC ANDA Current 37012-306 clearlax Polyethylene Glycol 3350 Shopko Stores Operating Co., LLC ANDA Current 37205-612 Leader Clear Lax Polyethylene Glycol 3350 Cardinal Health ANDA Current 37205-612 Leader Clear Lax Polyethylene Glycol 3350 Cardinal Health ANDA Current 37205-612 Leader Clear Lax Polyethylene Glycol 3350 Cardinal Health ANDA Current 37808-306 clear lax Polyethylene Glycol 3350 H E B ANDA Current 37808-306 clear lax Polyethylene Glycol 3350 H E B ANDA Current 37808-306 clear lax Polyethylene Glycol 3350 H E B ANDA Current 41163-306 equaline clearlax Polyethylene Glycol 3350 Supervalu Inc ANDA Current 41163-306 equaline clearlax Polyethylene Glycol 3350 Supervalu Inc ANDA Current 41163-306 equaline clearlax Polyethylene Glycol 3350 Supervalu Inc ANDA Current 41163-306 equaline clearlax Polyethylene Glycol 3350 Supervalu Inc ANDA Current 41163-306 equaline clearlax Polyethylene Glycol 3350 Supervalu Inc ANDA Current 41190-306 ShopRite Clear Laxative Polyethylene Glycol 3350 Wakefern Food Corporation ANDA Current 41190-306 ShopRite Clear Laxative Polyethylene Glycol 3350 Wakefern Food Corporation ANDA Current 41250-306 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41250-306 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41250-306 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41250-306 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41250-306 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41250-939 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41250-939 clear lax Polyethylene Glycol 3350 Meijer Distribution Inc ANDA Current 41520-306 care one clearlax Polyethylene Glycol 3350 American Sales Company ANDA Current 41520-306 care one clearlax Polyethylene Glycol 3350 American Sales Company ANDA Current 41520-306 care one clearlax Polyethylene Glycol 3350 American Sales Company ANDA Current 41520-306 care one clearlax Polyethylene Glycol 3350 American Sales Company ANDA Current 42507-306 clear lax Polyethylene Glycol 3350 HyVee Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31486 ORIG 2009-10-14