FDA.reportPublic FDA data

Application 217236

Type
ANDA
Sponsor
PATHEON SOFTGELS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTNoNo

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
A217236-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-1384e616aacf4f…
2026-08-18 06:07:402026-07A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-138072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-136a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217236-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2024-02-13a50c72e98297…

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 40 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENBest Choice (Valu Merchandisers Company)04b4ed2b-5f43-4151-b355-ca1bb469658d2023-08-31WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutionsfa99f5ec-0306-473b-827f-86cd0a7978ec2023-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENCare One (Retail Business Services, LLC.)b5e9bd39-d2c5-4a6c-b0da-8e41d633b31c2023-08-24WarningsName fallback
generic name: IBUPROFEN
Good Neighbor Pharmacy ibuprofenIBUPROFENAmerisource Bergen74b227c9-8341-44df-a763-cfeb371c0d282023-08-17WarningsName fallback
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENStrategic Sourcing Services LLCc363c80f-364a-4047-a246-a1fdeb98a4f02023-08-08WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFEN TABLETS USP, 200MGBETTER LIVING BRANDS, LLCeb60a1e5-fb6e-360f-e053-2a95a90ade042023-08-03WarningsName fallback
brand name: Ibuprofen
betr remedies ibuprofenIBUPROFENLive Betr LLC0a50820f-1dfa-45b5-824f-2c28822fc6c62023-07-26WarningsName fallback
generic name: IBUPROFEN
Good Sense IbuprofenIBUPROFENL. Perrigo Companyf9af5970-18ca-46d5-8d6c-c0fec22a66d52023-07-21WarningsName fallback
generic name: IBUPROFEN
good sense ibuprofenIBUPROFENL. Perrigo Company9164f7e8-81a0-4b71-a2b3-111b2a7541bb2023-07-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)eaa0a286-a0f0-4979-8af3-c5f4194283fd2023-06-22WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Rexall IbuprofenIBUPROFENDolgencorp, LLCd2dc2f71-c0cb-4e6d-85b9-fcf386e207a02023-06-06WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENProficient Rx LPe4bb22bb-6df6-4016-a023-0b454df9fb0b2023-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
basic care ibuprofenIBUPROFENAmazon.com Services LLC3329f487-675d-440c-b7c5-d17a2b0242752023-05-31WarningsName fallback
generic name: IBUPROFEN
CHILDRENS IBUPROFENIBUPROFENBluePoint Laboratoriesd71acfe2-4643-f50b-e053-2a95a90add8b2023-05-31WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7d544d8e-fa76-461f-9417-5f1873912eac2023-05-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Equate IbuprofenIBUPROFENWal-Mart Stores Inc153bc4ac-427d-426a-9bb8-665487e4b1692023-04-27WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENP & L Development, LLC1889faea-24a3-45ea-92de-8dc76b9ed5b42023-04-25WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENRITE AID CORPORATIONde158883-1175-18fc-e053-2995a90a3c962023-04-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED403ec259-3be1-4e0b-ab7b-fee213b7eabe2023-04-03WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENProficient Rx LP4ee828df-873d-4379-9a17-a805d97dfe042023-04-01WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.