FDA.reportPublic FDA data

Application 209017

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/SCOOPFULNoNo
002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350FOR SOLUTION;ORAL17GM/PACKETNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209017-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09
A209017-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-23

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 2 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209017-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2018-04-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209017-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2024-04-23a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
application applno (ANDA): 209017
application number: ANDA209017
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
application applno (ANDA): 209017
application number: ANDA209017
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurobindo Pharma Limitedb51f2223-8266-4d6c-bf32-58e53e73b54d2026-04-23WarningsExact identifier
application applno (ANDA): 209017
application number: ANDA209017
COMFORTLAXPOLYETHYLENE GLYCOL 3350Family Dollar Stores, LLC02a44a41-0039-f6ec-e063-6394a90ae6f12026-04-23WarningsExact identifier
application applno (ANDA): 209017
application number: ANDA209017
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurohealth LLCd3c77f3f-57aa-4e2d-88aa-731cbb22af702026-04-23WarningsExact identifier
application applno (ANDA): 209017
application number: ANDA209017
ndc (product): 58602-805

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58602-805Polyethylene Glycol 3350Polyethylene Glycol 3350Aurohealth LLCANDACurrent
58602-805Polyethylene Glycol 3350Polyethylene Glycol 3350Aurohealth LLCANDACurrent
58602-805Polyethylene Glycol 3350Polyethylene Glycol 3350Aurohealth LLCANDACurrent
58602-805Polyethylene Glycol 3350Polyethylene Glycol 3350Aurohealth LLCANDACurrent