FDA.reportPublic FDA data

Application 078682

Type
ANDA
Sponsor
BIONPHARMA INC

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 44.

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
A078682-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24c2088c7a36db…
2026-09-14 22:38:342026-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2484e616aacf4f…
2026-08-18 06:07:402026-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243f01610625f2…
2019-09-15 20:21 UTC2019-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-243a93d1ddd44b…

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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYfed2f7ae-2825-f967-e053-6294a90adc0a2023-10-05WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCardinal Health (Leader) 70000e751cb66-5fa5-4171-b061-da34aa10de6c2023-03-10WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENRite Aid Corporationa35f04f8-8c7f-5e23-e053-2995a90a30ff2023-02-08WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENWALGREEN COMPANY4ce20d2b-2dfb-4405-b545-dd1f67b2c5882022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Migraine ReliefIBUPROFENWALGREENS3d560acb-3334-4a39-9ab1-f131060e3b332022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYb9ff2469-22c7-fc70-e053-2a95a90abc492022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYbcd15c0f-8231-296f-e053-2995a90a280c2022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENWal-Mart Stores, Inc.9e5332ab-92bc-3a33-e053-2995a90a642d2022-12-28WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 49035-381
Dye-Free IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.d0eff659-6445-a56a-e053-2995a90a72e92022-12-27WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.553d16e1-928e-4919-bc53-6683a035e2b02022-12-27WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENKROGER COMPANY3b95dcbf-aef1-44b5-a2c4-5ce93c57ff1d2022-12-27WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.aa91952b-512f-0ead-e053-2995a90a94552022-12-21WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBionpharma Inc.ba89fbe6-546a-e10c-e053-2a95a90ade0c2022-12-20WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7f510feb-023c-4974-af6d-3e7a30cef3622022-11-07WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 55910-197
Migraine ReliefIBUPROFENBionpharma Inc.662ae0e0-bd44-4db4-8083-fc2e11d49abe2021-08-24WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBionpharma Inc.d7d00fe3-c537-486e-8156-9b56b550bff52019-09-06WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENWal-Mart Stores, Incc100129d-3754-4d0e-b754-76440d55944a2019-08-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 49035-228
Ibuprofen 200IBUPROFENWALGREEN COMPANY5fe0bdfa-1d5b-4657-a32b-f531b69bac0d2019-08-13WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCb234d42e-1333-48a1-8565-35d9759e80852019-03-29WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682

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 · 239 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
41250-292IbuprofenIbuprofenMEIJER DISTRIBUTION INC.ANDACurrent
41250-292IbuprofenIbuprofenMEIJER DISTRIBUTION INC.ANDACurrent
41250-293IbuprofenIbuprofenMEIJER DISTRIBUTION INC.ANDACurrent
41250-293IbuprofenIbuprofenMEIJER DISTRIBUTION INC.ANDACurrent
41520-195IbuprofenIbuprofenCare One (American Sales Company)ANDACurrent
41520-195IbuprofenIbuprofenCare One (American Sales Company)ANDACurrent
42507-131IbuprofenIbuprofenHy-VeeANDACurrent
42507-131IbuprofenIbuprofenHy-VeeANDACurrent
42507-131IbuprofenIbuprofenHy-VeeANDACurrent
42507-198IbuprofenIbuprofenHy-VeeANDACurrent
42507-198IbuprofenIbuprofenHy-VeeANDACurrent
42507-198IbuprofenIbuprofenHy-VeeANDACurrent
42507-408IbuprofenIbuprofenHy-VeeANDACurrent
42507-408IbuprofenIbuprofenHy-VeeANDACurrent
42507-408IbuprofenIbuprofenHy-VeeANDACurrent
46122-580IbuprofenIbuprofenAMERISOURCE BERGENANDACurrent
46122-580IbuprofenIbuprofenAMERISOURCE BERGENANDACurrent
46122-580IbuprofenIbuprofenAMERISOURCE BERGENANDACurrent
46122-593IbuprofenIbuprofenAMERISOURCE BERGENANDACurrent
46122-593IbuprofenIbuprofenAMERISOURCE BERGENANDACurrent
46122-593IbuprofenIbuprofenAMERISOURCE BERGENANDACurrent
49035-198IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-198IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-198IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-228IbuprofenIbuprofenWal-Mart Stores, IncANDACurrent
49035-381IbuprofenIbuprofenWal-Mart Stores, Inc.ANDACurrent
49035-381IbuprofenIbuprofenWal-Mart Stores, Inc.ANDACurrent
49035-381IbuprofenIbuprofenWal-Mart Stores, Inc.ANDACurrent
49035-408IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-408IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-408IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-598IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-598IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-598IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49348-568IbuprofenIbuprofenMcKesson (Sunmark)ANDACurrent
49738-198IbuprofenIbuprofenSMART SENSE (Kmart)ANDACurrent
49738-198IbuprofenIbuprofenSMART SENSE (Kmart)ANDACurrent
49738-198IbuprofenIbuprofenSMART SENSE (Kmart)ANDACurrent
50580-120Motrin IB MigraineIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-409Motrin IBIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-409Motrin IBIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-409Motrin IBIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-409Motrin IBIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50804-199IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-199IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-199IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-199IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-199IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-199IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50844-754IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
50844-754IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
50844-754IbuprofenIbuprofenL.N.K. International, Inc.ANDACurrent
53187-199IbuprofenIbuprofenLIVE BETTER (The Great Atlantic & Pacific Tea Company)ANDACurrent
53187-199IbuprofenIbuprofenLIVE BETTER (The Great Atlantic & Pacific Tea Company)ANDACurrent
53187-199IbuprofenIbuprofenLIVE BETTER (The Great Atlantic & Pacific Tea Company)ANDACurrent
53943-212IBUPROFENIbuprofenDISCOUNT DRUG MART, INC.ANDACurrent
53943-212IBUPROFENIbuprofenDISCOUNT DRUG MART, INC.ANDACurrent
53943-214IbuprofenIbuprofenDISCOUNT DRUG MART, INC.ANDACurrent
53943-214IbuprofenIbuprofenDISCOUNT DRUG MART, INC.ANDACurrent
55301-199IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55301-199IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55301-199IbuprofenIbuprofenAAFES/Your Military ExchangesANDACurrent
55312-197IbuprofenIbuprofenWestern Family Foods, Inc.ANDACurrent
55315-199IbuprofenIbuprofenFreds IncANDACurrent
55316-131IbuprofenIbuprofenHealthy Accents (DZA Brands, LLC)ANDACurrent
55316-131IbuprofenIbuprofenHealthy Accents (DZA Brands, LLC)ANDACurrent
55316-198IbuprofenIbuprofenHealthy Accents (DZA Brands, LLC)ANDACurrent
55316-198IbuprofenIbuprofenHealthy Accents (DZA Brands, LLC)ANDACurrent
55319-199IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-199IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-199IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55910-197IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-197IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-197IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-199IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-408IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-408IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-408IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
56062-199IbuprofenIBUPROFENPublix Supermarkets, Inc.ANDACurrent
56062-199IbuprofenIBUPROFENPublix Supermarkets, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65844SUPPL2021-01-07
65843SUPPL2021-01-07
65842SUPPL2021-01-07
43144ORIG2011-09-19
23916ORIG2009-04-14