Home Applications 203928 Application 203928
Type ANDA
Sponsor STRIDES PHARMA 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/SCOOPFUL No No 002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 FOR SOLUTION;ORAL 17GM/PACKET No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A203928-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 A203928-002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24
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 · 84 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 2026-08-18 06:07:40 2026-07 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203928-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2016-08-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203928-002 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2016-08-24 bb7c543d1eb4…
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 1 · 16 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 The Fresh Test, LLC cb8e182f-c23f-4f8d-9c09-24e19b2e914e 2026-08-05 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 INSTALAX POLYETHYLENE GLYCOL 3350 Sun Pharmaceutical Industries, Inc. 40bd1be7-de67-8dff-e063-6294a90aca95 2026-07-24 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Strides Pharma Inc 77b9060f-c9ab-4047-b1f1-063956678453 2026-07-15 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 59556-762 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 4e8b6a32-11ec-4419-9ec8-aaa182389972 2026-06-19 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 55154-8091 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 PIONEER LIFE SCIENCES, LLC 478f104a-0e50-479c-8722-a3f1eab68691 2026-06-11 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals ddc9d2b1-87d8-44fa-bac6-0a7261f33564 2026-05-12 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 0904-6931 Mix-In Laxative Packets POLYETHYLENE GLYCOL 3350 Wal-Mart Stores Inc 0347c934-1e85-4f8d-8d35-bb07f16810ad 2026-04-10 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 49035-906 ez2go Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Valley Medical Products, LLC d64517d6-b0cc-4ba2-b260-e52faa8d4e78 2026-02-20 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 American Health Packaging 81374641-e54c-4b41-a3ad-49b19a097666 2026-02-18 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 60687-431 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 GLENMARK THERAPEUTICS INC., USA 5aba6bb1-d25d-4901-8e9c-4cd4a3a06471 2026-01-27 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 Powder for Solution POLYETHYLENE GLYCOL, UNSPECIFIED VALLEY MEDICAL PRODUCTS, LLC ae595e97-6d29-44f8-a647-fcd54fcda5b1 2025-10-27 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 4d524ace-9de5-4f62-9263-7cd88a36b67c 2025-10-24 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 55154-8184 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC e26457c4-03e8-430e-bfad-38ae105dbf6f 2025-10-23 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 55154-2328 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 2f5c975f-0d35-4f68-a27c-28af9a898733 2025-10-23 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 55154-8090 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Kesin Pharma Corporation 3729a1d2-4c98-dfdf-e063-6394a90a5a87 2025-06-12 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Gericare Pharmaceuticals 5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd 2022-10-28 Warnings Exact identifier application applno (ANDA): 203928 application number: ANDA203928 ndc (product): 57896-490
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 33 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0904-6931 Polyethylene glycol 3350 Polyethylene glycol 3350 Major Pharmaceuticals ANDA Current 0904-6931 Polyethylene glycol 3350 Polyethylene glycol 3350 Major Pharmaceuticals ANDA Current 0904-6931 Polyethylene glycol 3350 Polyethylene glycol 3350 Major Pharmaceuticals ANDA Current 0904-6931 Polyethylene glycol 3350 Polyethylene glycol 3350 Major Pharmaceuticals ANDA Current 0904-6931 Polyethylene glycol 3350 Polyethylene glycol 3350 Major Pharmaceuticals ANDA Current 0904-6931 Polyethylene glycol 3350 Polyethylene glycol 3350 Major Pharmaceuticals ANDA Current 49035-906 Mix-In Laxative Packets Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-906 Mix-In Laxative Packets Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-906 Mix-In Laxative Packets Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-906 Mix-In Laxative Packets Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 49035-906 Mix-In Laxative Packets Polyethylene Glycol 3350 Wal-Mart Stores Inc ANDA Current 55154-2328 Polyethylene glycol 3350 Polyethylene glycol 3350 Cardinal Health 107, LLC ANDA Current 55154-2328 Polyethylene glycol 3350 Polyethylene glycol 3350 Cardinal Health ANDA Current 55154-8090 Polyethylene glycol 3350 Polyethylene glycol 3350 Cardinal Health 107, LLC ANDA Current 55154-8090 Polyethylene glycol 3350 Polyethylene glycol 3350 Cardinal Health ANDA Current 55154-8091 Polyethylene glycol 3350 Polyethylene glycol 3350 Cardinal Health 107, LLC ANDA Current 55154-8091 Polyethylene glycol 3350 Polyethylene glycol 3350 Cardinal Health ANDA Current 55154-8184 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Cardinal Health 107, LLC ANDA Current 55154-8184 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Cardinal Health ANDA Current 55154-8184 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Cardinal Health ANDA Current 57896-490 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Gericare Pharmaceuticals ANDA Current 57896-490 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Gericare Pharmaceuticals ANDA Current 57896-490 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Gericare Pharmaceuticals ANDA Current 57896-490 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Gericare Pharmaceuticals ANDA Current 57896-490 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Gericare Pharmaceuticals ANDA Current 59556-762 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Strides Pharma Inc ANDA Current 59556-762 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Strides Pharma Inc ANDA Current 59556-762 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Strides Pharma Inc ANDA Current 59556-762 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Strides Pharma Inc ANDA Current 60687-431 Polyethylene Glycol 3350 Polyethylene Glycol 3350 American Health Packaging ANDA Current 60687-431 Polyethylene Glycol 3350 Polyethylene Glycol 3350 American Health Packaging ANDA Current 60687-431 Polyethylene Glycol 3350 Polyethylene Glycol 3350 American Health Packaging ANDA Current 63940-762 Polyethylene Glycol Polyethylene Glycol Harmon Stores, Inc ANDA Current