Home Applications 200457 Application 200457
Type ANDA
Sponsor ARISE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN SUSPENSION;ORAL 100MG/5ML No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200457-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200457-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2011-08-18 f41ea6bd6efb…
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 37 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join dg health ibuprofen IBUPROFEN Dolgencorp Inc b514b589-d965-4a21-91b3-fab4019e9d96 2024-04-12 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN H E B e00acbc0-352e-4ba1-8433-18a3079f6743 2024-04-12 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Infants Ibuprofen IBUPROFEN Aurohealth LLC 2a48af51-23e2-4fec-a76b-eef1611750f5 2024-04-10 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Sam's West, Inc 74ad11b9-8976-463d-89a3-2b9f5acd0c80 2024-04-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Advil Liqui-Gels IBUPROFEN Lil Drug Store Products, Inc ba5a9a04-993e-4fd6-bb40-6edfdfb69b34 2024-03-27 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN NuCare Pharmaceuticals,Inc. 141b7964-cce6-74e4-e063-6294a90af746 2024-03-20 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN EXELAN PHARMACEUTICALS, INC. 362f934a-4382-43bc-bedd-65081286f1c9 2024-03-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN WALGREENS 746f79aa-3036-1b9b-e053-2a91aa0a1db6 2024-03-18 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN IBUPROFEN IBUPROFEN WALGREENS 76f4cc25-a77e-6245-e053-2a91aa0af7ae 2024-03-18 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN IBUPROFEN IBUPROFEN WALGREENS 3ce5b71b-f841-444f-bf66-023e4bd9aa16 2024-03-15 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN IBUPROFEN IBUPROFEN WALGREENS 76f15be2-4682-5015-e053-2991aa0af0d2 2024-03-15 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN basic care ibuprofen IBUPROFEN Amazon.com Services LLC 5ada3dbe-af87-49db-a6b0-0a1c02111cbf 2024-03-11 Warnings Name fallback generic name: IBUPROFEN CHILDRENS ADVIL IBUPROFEN Haleon US Holdings LLC 3079d932-afb2-94fe-f4ba-a3d8b5198fce 2024-02-08 Warnings Name fallback generic name: IBUPROFEN CHILDRENS ADVIL IBUPROFEN Haleon US Holdings LLC 4eba2795-e826-480d-afdc-d62004e95f36 2024-02-08 Warnings Name fallback generic name: IBUPROFEN pain relief IBUPROFEN Meijer, Inc. 1f965703-3262-4dd1-b4f8-6341786553b1 2024-02-07 Warnings Name fallback generic name: IBUPROFEN signature care ibuprofen IBUPROFEN Safeway 95904b21-752d-48b4-a882-8d81d2384e1f 2024-02-01 Warnings Name fallback generic name: IBUPROFEN Childrens FLANAX ORAL IBUPROFEN Belmora LLC 9b9318cb-3bc7-40ca-bf8a-7495d93869b3 2024-01-30 Warnings Name fallback generic name: IBUPROFEN good sense ibuprofen IBUPROFEN A-S Medication Solutions 57af05fc-30b9-4487-9a37-fb35dac4acf7 2024-01-29 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN A-S Medication Solutions fd691a4a-8010-45e6-b3da-b26374792f24 2024-01-26 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN IBUPROFEN IBUPROFEN HART Health 1c1374e1-890f-48ab-8f93-e84da9d5bf84 2024-01-25 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN
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 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65162-672 Ibuprofen Ibuprofen Amneal Pharmaceuticals ANDA Current