FDA.reportPublic FDA data

Application 071668

Type
ANDA
Sponsor
PLIVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

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
A071668-001IBUPROFENIBUPROFEN800MGTABLET / ORAL1987-06-18

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 22:38:342026-08A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-1884e616aacf4f…
2026-08-18 06:07:402026-07A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-183f01610625f2…
2019-09-15 20:21 UTC2019-09A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071668-001IBUPROFEN800MGTABLET / ORAL1987-06-18f41ea6bd6efb…

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 16 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c85b-2ba5-32c3-e063-6294a90af1482025-12-19WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen Oral SuspensionIBUPROFENMarc Glassman, Inc.0ef3f4b3-9af5-4243-8d45-dd68f72852292025-12-19WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENWALGREENS CO.b8a77b7e-e161-b3ac-e053-2995a90af3e82025-12-19WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
Childrens Ibuprofen Oral SuspensionIBUPROFENDiscount Drug Mart7b7954b7-e4c8-4284-a649-31a4eb6ba73e2025-12-19WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENWalgreens07edb8d0-2fa8-4b40-e063-6294a90a2fe92025-12-19WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENFamily Dollarfe17f5a6-fd6d-d839-e053-6394a90a59a42025-12-19WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutionsf24582be-8d70-4848-bd54-e55fa28f394f2025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENNuCare Pharmaceuticals, Inc.463ea713-6b27-b00b-e063-6394a90a86462025-12-18WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3c1a61b-88fc-419c-e053-2a95a90ac0c32025-12-18WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.8c3ca03e-0ec2-c15c-e053-2995a90ad8bd2025-12-18WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutionse5db46f3-043b-40ac-a89b-c90bd562e7b42025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions3db0c659-cc43-45dc-8442-bc89093d94d72025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMajor Pharmaceuticals6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f62025-12-17WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.96bff700-bca3-4b94-b8a2-379102721db82025-12-15WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
topcare childrens ibuprofenIBUPROFENTopco Associates LLCd1bb68a6-3a29-4a4e-b4e9-413cc8d161912025-12-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY7e2ab4f1-2e87-4fbf-8882-e4d20aef142c2025-12-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANYa42f96c4-322d-4714-9435-7b5a4e8b6ae52025-12-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY02e4418a-93ed-2212-e063-6294a90a6c8a2025-12-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY88b3f388-46d3-4e42-98fb-0351c76a15fc2025-12-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENVALU MERCHANDISERS COMPANY36b95840-f621-437a-bf49-406d320964da2025-12-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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