Application 072299

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

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
A072299-001IBUPROFENIBUPROFEN200MGTABLET / ORAL1988-07-01

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 22:38:342026-08A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-0184e616aacf4f…
2026-08-18 06:07:402026-07A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-013f01610625f2…
2019-09-15 20:21 UTC2019-09A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A072299-001IBUPROFEN200MGTABLET / ORAL1988-07-01f41ea6bd6efb…

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 14 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENHYVEE INC459fc670-32a3-61a6-e063-6294a90aea5a2026-01-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.8ebe3e16-b7ae-d333-6671-5bc935e259002026-01-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENHyVee Inc2fd51545-1d1f-4b2e-a084-d28ba223e7202026-01-13WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
ibuprofen infantsIBUPROFENHyVee Ince8fcaf17-234a-4d64-b621-9ca505884b0a2026-01-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c2026-01-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMeijer Distribution Incc0c64ba5-b6b0-4221-9e44-110d92c937822026-01-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCoupler LLC4831785a-cde2-79a2-e063-6294a90a9a402026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENL.N.K. International, Inc.c93da67f-f42e-4baa-976b-73c71ba6dd712026-01-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
GOOD SENSE CHILDRENS IBUPROFENIBUPROFENL. Perrigo Companycd06ffc5-4921-4b2d-88ea-939fa4daf59c2026-01-09WarningsName fallback
generic name: IBUPROFEN
Xpect IbuprofenIBUPROFENCintas Corporation976ba88a-6428-40d1-a2fd-eac64963ba1d2026-01-08WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENStrides Pharma Inc69b208ff-83f5-40d1-a2ff-d54b390e46e42026-01-08WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
ibuprofenIBUPROFENCVS Pharmacyace493e6-91bc-41aa-8e5c-5bc14981de912026-01-06WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENSafeway, Inc.22927a12-6837-4d57-8e60-043000f2f2082026-01-05WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENDOLGENCORP, LLC37ccb303-c70e-48b3-a8a3-2b0097cf8f882026-01-05WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
DG Health IbuprofenIBUPROFENDolgencorp Inc1dd4ffc5-3132-419b-8e70-78a7bb71da622026-01-02WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthwind Health Company, LLC2f12a20c-4293-d18a-e063-6294a90a3afc2026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthwind Health Company, LLCc20f1f4d-59b3-6bbe-e053-2a95a90abaf12026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthwind Health Company, LLCab313564-27dc-0297-e053-2a95a90a66902026-01-01WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthwind Health Company, LLCdac07d8f-6b6f-20ab-e053-2a95a90af3ba2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNorthwind Health Company, LLCda6c72ad-009f-3d7f-e053-2995a90a68e92026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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