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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078682-001IBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2009-03-24e64feba35796…

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 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen mini dye freeIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.552d9018-cc7e-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)fb842f4d-1228-9a52-e053-6294a90adb412026-06-26WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
Ibuprofen Mini Dye FreeIBUPROFENCVS Pharmacy42c7dbec-2e53-70ae-e063-6294a90a16e62026-06-25WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c62cc12f-5a0e-389a-e053-2995a90a208c2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)c6297c23-3b27-c0c6-e053-2995a90a3e762026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a139e495-3dbf-4998-e053-2a95a90ac1362026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
pain reliefIBUPROFENBionpharma Inc.a14ca126-fada-c903-e053-2995a90ae72d2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 69452-262
IbuprofenIBUPROFENHEBca4be24c-5d92-ddc9-e053-2a95a90aa5a72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDOLGENCORP INC03138a6f-653a-f359-e063-6394a90ac5d62026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFEN CAPSULEPUBLIX SUPER MARKETS INC10a6eba7-e400-ce97-e063-6294a90af3bd2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IBUPROFENIBUPROFENDISCOUNT DRUG MART, INC.d07ea9e3-88b0-4aa0-903a-10555dcca37d2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENDISCOUNT DRUG MART, INC.aae40114-343e-12da-e053-2a95a90a92132026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENBJWC0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a2026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 68391-212
pain reliefIBUPROFENBionpharma Inc.2b4ecdd8-627a-445f-8ddc-f2b6c832c1e82026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 69452-260
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
ndc (product): 69452-302
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.4573753d-117b-a6f2-e063-6394a90ae2f92026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3ed7faff-fd48-0a83-e063-6394a90aab142026-06-23WarningsExact identifier
application applno (ANDA): 078682
application number: ANDA078682

NDC Listings For This Application#

NDC listings for this application page 3 of 3 · 239 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59726-022IbuprofenIBUPROFENP & L Development, LLCANDACurrent
59726-120IbuprofenIbuprofenPL DevelopmentsANDACurrent
59726-199IbuprofenIbuprofenP & L Development, LLCANDACurrent
59726-199IbuprofenIbuprofenP & L Development, LLCANDACurrent
59779-108IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-108IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-197IbuprofenIbuprofenCVS PharmacyANDACurrent
59779-197IbuprofenIbuprofenCVS PharmacyANDACurrent
61715-054IbuprofenIbuprofenPreferred Plus (Kinray)ANDACurrent
61715-054IbuprofenIbuprofenPreferred Plus (Kinray)ANDACurrent
62011-0016IBUPROFENIBUPROFENMcKesson (Health Mart)ANDACurrent
62011-0016IBUPROFENIBUPROFENStrategic Sourcing Services LLCANDACurrent
62011-0016IBUPROFENIBUPROFENStrategic Sourcing Services LLCANDACurrent
63868-427IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63868-427IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63868-428IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-470IbuprofenIbuprofenChain Drug Marketing Association, Inc.ANDACurrent
63868-470IbuprofenIbuprofenChain Drug Marketing Association, Inc.ANDACurrent
63868-759IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-759IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-759IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-805Dye-Free IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63868-805Dye-Free IbuprofenIbuprofenCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63940-199IbuprofenIBUPROFENHarmon StoresANDACurrent
63940-199IbuprofenIBUPROFENHarmon StoresANDACurrent
63941-199IbuprofenIbuprofenBest Choice (Valu Merchandisers Company)ANDACurrent
63981-199IbuprofenIBUPROFENCostco WholesaleANDACurrent
63981-199IbuprofenIBUPROFENCostco WholesaleANDACurrent
63981-598IbuprofenIBUPROFENCostco WholesaleANDACurrent
63981-598IbuprofenIBUPROFENCostco WholesaleANDACurrent
63981-598IbuprofenIBUPROFENCostco WholesaleANDACurrent
67091-141IbuprofenIbuprofenWinCo Foods, LLCANDACurrent
67091-141IbuprofenIbuprofenWinCo Foods, LLCANDACurrent
67091-141IbuprofenIbuprofenWinCo Foods, LLCANDACurrent
68016-116IbuprofenIbuprofenChain Drug Consortium, LLCANDACurrent
68016-116IbuprofenIbuprofenChain Drug Consortium, LLCANDACurrent
68016-626IbuprofenIbuprofenChain Drug Consortium, LLCANDACurrent
68196-199IbuprofenIbuprofenSam's West, IncANDACurrent
68196-199IbuprofenIbuprofenSam's West, IncANDACurrent
68391-199IbuprofenIbuprofenBJWC (Berkley & Jensen / BJ's)ANDACurrent
68391-199IbuprofenIbuprofenBJWC (Berkley & Jensen / BJ's)ANDACurrent
68391-199IbuprofenIbuprofenBJWC (Berkley & Jensen / BJ's)ANDACurrent
68391-212IbuprofenIbuprofenBJWCANDACurrent
68391-212IbuprofenIbuprofenBJWCANDACurrent
69256-199IbuprofenIBUPROFENHarris Teeter, LLCANDACurrent
69256-199IbuprofenIBUPROFENHarris Teeter, LLCANDACurrent
69452-212IbuprofenIbuprofenBionpharma Inc.ANDACurrent
69452-212IbuprofenIbuprofenBionpharma Inc.ANDACurrent
69452-212IbuprofenIbuprofenBionpharma Inc.ANDACurrent
69452-239IbuprofenIbuprofenBionpharma Inc.ANDACurrent
69452-260pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-260pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-262pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-262pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-262pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-263Migraine ReliefIbuprofenBionpharma Inc.ANDACurrent
69452-263Migraine ReliefIbuprofenBionpharma Inc.ANDACurrent
69452-302dye-free pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-302dye-free pain reliefIbuprofenBionpharma Inc.ANDACurrent
69452-305IbuprofenIbuprofenBionpharma Inc.ANDACurrent
69452-305IbuprofenIbuprofenBionpharma Inc.ANDACurrent
69842-892Ibuprofen MigraineIbuprofenCVS PharmacyANDACurrent
69842-892Ibuprofen MigraineIbuprofenCVS PharmacyANDACurrent
70000-0172IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0172IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0172IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0197IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0197IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0197IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0571IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70000-0571IbuprofenIbuprofenCardinal Health (Leader) 70000ANDACurrent
70253-199IbuprofenIBUPROFENOUR FAMILY (Nash Finch Company)ANDACurrent
70469-199IbuprofenIbuprofenCapsule CorporationANDACurrent
70469-199IbuprofenIbuprofenCapsule CorporationANDACurrent
70677-0046IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
70677-0046IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
70677-0046IbuprofenIbuprofenStrategic Sourcing Services LLCANDACurrent
70677-0046IbuprofenIbuprofenMcKesson (Sunmark)ANDACurrent
82649-199IbuprofenIBUPROFENLifeMDANDACurrent

Documents#

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