Home Applications 077706 Application 077706
Type ANDA
Sponsor NEXGEN PHARMA INC 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077706-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27
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 2 · 43 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 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077706-001 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2006-09-27 f41ea6bd6efb…
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 5 · 94 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join leader clearlax POLYETHYLENE GLYCOL 3350 Cardinal Health 110, LLC. dba Leader 812c59b0-e7ce-4c7a-91ed-e74b7b1b84be 2026-09-22 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 L.N.K. International, Inc. bbc11078-73f7-4d27-b0d3-4d4ae5dae240 2026-09-10 Warnings Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350 CLEARLAX POLYETHYLENE GLYCOL 3350 Amazon.com Services LLC 7ed915ec-7e99-4e0e-aca0-20718987a88c 2026-09-08 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 purelax POLYETHYLENE GLYCOL 3350 CVS Pharmacy fc3b6006-a75a-41b3-9f0b-a3152df1363f 2026-09-04 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 basic care clearlax POLYETHYLENE GLYCOL 3350 Amazon.com Services LLC 1ccb8604-34f6-4e1e-beed-eb81d6aa7aef 2026-09-03 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 purelax POLYETHYLENE GLYCOL 3350 CVS Pharmacy 006a9eca-400f-47f5-bee5-facf7034043e 2026-09-02 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 Kroger POLYETHYLENE GLYCOL 3350 KROGER COMPANY c56271ff-703a-40c4-840f-1962798c9e42 2026-09-02 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 gentle lax POLYETHYLENE GLYCOL 3350 Kroger Company 0d820dcc-440a-4036-86e9-fdb30cac9573 2026-09-01 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 CLEARLAX POLYETHYLENE GLYCOL 3350 Amazon.com Services LLC bd33463b-eb1a-41ed-92d1-f50d0923eb3b 2026-08-31 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 4d524ace-9de5-4f62-9263-7cd88a36b67c 2026-08-28 Warnings Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350 PEG3350 POLYETHYLENE GLYCOL 3350 Major Pharmaceuticals 161629f6-6193-4712-bba7-7d5b174a9338 2026-08-28 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 Mix-In Laxative Packets POLYETHYLENE GLYCOL 3350 Wal-Mart Stores Inc 0347c934-1e85-4f8d-8d35-bb07f16810ad 2026-08-27 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Preferred Pharmaceuticals Inc. cccbe459-813d-4668-8cd2-76be82906a32 2026-08-17 Warnings Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 The Fresh Test, LLC cb8e182f-c23f-4f8d-9c09-24e19b2e914e 2026-08-05 Warnings Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 INSTALAX POLYETHYLENE GLYCOL 3350 Sun Pharmaceutical Industries, Inc. 40bd1be7-de67-8dff-e063-6294a90aca95 2026-07-24 Warnings Name fallback brand name: Polyethylene Glycol 3350 clear lax POLYETHYLENE GLYCOL 3350 HyVee Inc 5bcf01d8-ddf3-4e64-8d3f-3526a51a5859 2026-07-02 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 CLEARLAX POLYETHYLENE GLYCOL 3350 Safeway a70f41d0-0fad-4d15-8844-d60eabeb6732 2026-07-02 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350 Polyethylene glycol 3350 POLYETHYLENE GLYCOL 3350 Cardinal Health 107, LLC 4e8b6a32-11ec-4419-9ec8-aaa182389972 2026-06-19 Warnings Name fallback brand name: Polyethylene glycol 3350 generic name: POLYETHYLENE GLYCOL 3350 Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 PIONEER LIFE SCIENCES, LLC 478f104a-0e50-479c-8722-a3f1eab68691 2026-06-11 Warnings Name fallback brand name: Polyethylene Glycol 3350 generic name: POLYETHYLENE GLYCOL 3350 365 WHOLE FOODS MARKET Polyethylene Glycol 3350 POLYETHYLENE GLYCOL 3350 Whole Foods Market, Inc. b19f42a9-18ac-4d23-87b5-3c43e47c4054 2026-06-05 Warnings Name fallback generic name: POLYETHYLENE GLYCOL 3350
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 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0722-6920 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Nexgen Pharma, Inc. ANDA Current 0722-6921 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Nexgen Pharma, Inc. ANDA Current 17856-0457 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Atlantic Biologicals Corps ANDA Current 35356-544 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ANDA Current 51991-457 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Breckenridge Pharmaceutical, Inc. ANDA Current 68071-1316 Polyethylene Glycol 3350 Polyethylene Glycol 3350 NuCare Pharmaceuticals,Inc. ANDA Current 68071-1316 Polyethylene Glycol 3350 Polyethylene Glycol 3350 NuCare Pharmaceuticals,Inc. ANDA Current 68071-1316 Polyethylene Glycol 3350 Polyethylene Glycol 3350 NuCare Pharmaceuticals,Inc. ANDA Current 71205-011 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Proficient Rx LP ANDA Current 71205-011 Polyethylene Glycol 3350 Polyethylene Glycol 3350 Proficient Rx LP ANDA Current