FDA.reportPublic FDA data

Application 076652

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYCOLAXPOLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076652-001GLYCOLAXPOLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0284e616aacf4f…
2026-08-18 06:07:402026-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076652-001GLYCOLAX17GM/SCOOPFULFOR SOLUTION / ORAL2004-07-02f41ea6bd6efb…

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 2 of 5 · 93 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurobindo Pharma Limitedb51f2223-8266-4d6c-bf32-58e53e73b54d2026-04-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
COMFORTLAXPOLYETHYLENE GLYCOL 3350Family Dollar Stores, LLC02a44a41-0039-f6ec-e063-6394a90ae6f12026-04-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurohealth LLCd3c77f3f-57aa-4e2d-88aa-731cbb22af702026-04-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
equate clear laxPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc56a507f3-0cd1-4f02-9dfd-de297ba4bc1f2026-03-27WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
foster and thrive clearlaxPOLYETHYLENE GLYCOL 3350Strategic Sourcing Services LLC684e35cc-5a4f-458d-b5e7-e1933fea11392026-03-07WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
ez2go Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Valley Medical Products, LLCd64517d6-b0cc-4ba2-b260-e52faa8d4e782026-02-20WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350American Health Packaging81374641-e54c-4b41-a3ad-49b19a0976662026-02-18WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350GLENMARK THERAPEUTICS INC., USA5aba6bb1-d25d-4901-8e9c-4cd4a3a064712026-01-27WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals Inc.935f05da-3637-4a9e-843e-1f2ced5d1a742026-01-23WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350YYBA Corp48488531-5d04-4af6-e063-6294a90afe4b2026-01-13WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350ANI Pharmaceuticals, Inc.1afff730-b2d3-4e01-8403-97f2ecef3a742025-12-10WarningsName fallback
generic name: POLYETHYLENE GLYCOL 3350
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsName 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62175-442POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Lannett Company, Inc..ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43095ORIG2007-07-20