Application 206568

Type
ANDA
Sponsor
HUMANWELL PURACAP

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
A206568-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21

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 22:38:342026-08A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2184e616aacf4f…
2026-08-18 06:07:402026-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206568-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2016-06-21f41ea6bd6efb…

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENWalgreens6d1d131d-0741-4a75-8383-9322f4f3faab2026-08-06WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENP & L Development, LLCd0301d0d-fc65-420f-87fd-a08da1584d542026-06-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
ndc (product): 59726-745
Ibuprofen MinisIBUPROFENVivunt Pharma LLCc46803db-feb7-435c-ac42-cffa99d35f462026-06-04WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCVS Pharmacy121b13c8-0b1a-4c48-9d57-3b53a9228d342026-05-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENCVS Pharmacya6fc144a-6826-4bf7-8efb-8cdb896387f12026-05-12WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENSafeway, Inc.22927a12-6837-4d57-8e60-043000f2f2082026-01-05WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46a9424c-fd7d-f88b-e063-6294a90abceb2025-12-24WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)3a02af7e-7e69-45a6-97d7-ddc7d92b28b32025-10-22WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen MinisIBUPROFENFamily Dollar (FAMILY WELLNESS)72f933d8-cf01-4bb6-a552-e3cdb297038b2025-10-21WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCVS Pharmacye241ca5f-04bd-4bc9-bd0c-ca22841c4a3c2025-07-01WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENChain Drug Consortium, LLCf0f01b97-e52c-4077-a4c6-c59736f4c1712025-06-30WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
Ibuprofen minisIBUPROFENP & L Development, LLC18b79fc5-57c8-46f1-81f3-2f9e189cdbcb2025-05-16WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
ndc (product): 59726-843
IbuprofenIBUPROFENAAFES/Your Military Exchanges773b0230-a3a3-44e0-a22b-d143796ca3652025-05-08WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
ndc (product): 55301-745
Ibuprofen minisIBUPROFENWR Group, Inc.e9dad35a-6789-42d6-97da-521db7b164962025-03-24WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENCare One (Retail Business Services, LLC.)a6ce7484-7a32-4985-80bc-883c31be35252025-03-12WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENRugby Laboratories, Inc.05c4e6c7-bf95-4e05-b7da-7a8778de342b2024-10-28WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568
IbuprofenIBUPROFENP & L Development, LLC1f9c94a6-938a-420f-b90c-36b3791e97ad2024-10-07WarningsExact identifier
application applno (ANDA): 206568
application number: ANDA206568

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 2 of 3 · 214 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49035-265Ibuprofen minisIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-745IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-745IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-745IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-745IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-749IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-749IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-749IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49738-745IbuprofenIbuprofenSMART SENSE (Kmart)ANDACurrent
49738-745IbuprofenIbuprofenSMART SENSE (Kmart)ANDACurrent
49738-745IbuprofenIbuprofenSMART SENSE (Kmart)ANDACurrent
50594-843Ibuprofen minisIbuprofenBig LotsANDACurrent
50594-843Ibuprofen minisIbuprofenBig LotsANDACurrent
50594-843Ibuprofen minisIbuprofenBig LotsANDACurrent
51013-103IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-103IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-405IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-405IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-410IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-410IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-421IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-421IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-422IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-422IbuprofenIbuprofenPuraCap Pharmaceutical LLCANDACurrent
51013-429IbuprofenIbuprofenPURACAP PHARMACEUTICAL LLCANDACurrent
51013-429IbuprofenIbuprofenPURACAP PHARMACEUTICAL LLCANDACurrent
53345-014IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-014IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-014IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-014IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-014IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-014IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-039IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-039IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-039IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-039IbuprofenIbuprofenHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
53345-050Ibuprofen miniIbuprofen miniHumanwell PuraCap Pharmaceutical (Wuhan) Co., LtdANDACurrent
55301-745IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55301-745IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55301-745IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55301-745IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55301-745IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55319-745IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-745IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-843Ibuprofen minisIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-843Ibuprofen minisIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-843Ibuprofen minisIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55910-741IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-741IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-741IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-741IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-845IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-845IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-845IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-849IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-849IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-849IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-849IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-953Ibuprofen minisIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-953Ibuprofen minisIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-953Ibuprofen minisIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-953Ibuprofen minisIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
59726-745IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-745IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-745IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-745IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-745IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-843Ibuprofen minisIbuprofenP & L Development, LLCANDACurrent
59726-843Ibuprofen minisIbuprofenP & L Development, LLCANDACurrent
59726-843Ibuprofen minisIbuprofenP & L Development, LLCANDACurrent
59726-843Ibuprofen minisIbuprofenP & L Development, LLCANDACurrent
62011-0368IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0368IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0368IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0368IbuprofenIbuprofenMcKesson (Health Mart)ANDACurrent
62011-0399Ibuprofen MinisIbuprofenMcKesson (Health Mart)ANDACurrent
62011-0399Ibuprofen MinisIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0399Ibuprofen MinisIbuprofenStrategic Sourcing Services LLCANDACurrent
62011-0399Ibuprofen MinisIbuprofenStrategic Sourcing Services LLCANDACurrent
63868-239IbuprofenIbuprofenChain Drug Marketing Association Inc.ANDACurrent