Home Applications 204062 Application 204062
Type ANDA
Sponsor HEC PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 400MG No No 002 IBUPROFEN IBUPROFEN TABLET;ORAL 600MG No No 003 IBUPROFEN IBUPROFEN TABLET;ORAL 800MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204062-001 IBUPROFEN IBUPROFEN 400MG TABLET / ORAL 2018-09-10 A204062-002 IBUPROFEN IBUPROFEN 600MG TABLET / ORAL 2018-09-10 A204062-003 IBUPROFEN IBUPROFEN 800MG TABLET / ORAL 2018-09-10
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 4 · 129 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 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204062-002 IBUPROFEN 600MG TABLET / ORAL 2018-09-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204062-003 IBUPROFEN 800MG TABLET / ORAL 2018-09-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204062-001 IBUPROFEN 400MG TABLET / ORAL 2018-09-10 301d65b070ca…
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 45 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join IBUPROFEN IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 77adb094-869c-44b4-8a4e-b739ac9cd701 2021-04-20 Name fallback brand name: IBUPROFEN generic name: IBUPROFEN IBU IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd 2021-01-21 Boxed warning, Warnings, Adverse reactions Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Proficient Rx LP 924d2dd0-3b7d-42ec-b617-86729dba2b95 2021-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Proficient Rx LP e23eb275-ce0c-40ec-b809-a48c5e46c7ec 2021-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Proficient Rx LP 8813a8a4-ebbd-4204-88a3-600a92ea9170 2020-12-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN CVS Pharmacy 60fd517d-608b-473e-8a44-eb9842459997 2020-10-22 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IB IBUPROFEN WINCO FOODS, LLC 9d78644d-83c7-46d1-8156-0d76acb7c299 2020-09-17 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IB IBUPROFEN WINCO FOODS, LLC ee867519-227f-44ba-ba8b-2dbefcc9fc67 2020-09-17 Warnings Name fallback generic name: IBUPROFEN basic care childrens ibuprofen IBUPROFEN Amazon.com Services LLC 18e5eed7-d3be-4559-93ca-b40ee26c7bd8 2020-09-09 Warnings Name fallback generic name: IBUPROFEN Basic Care Childrens Ibuprofen IBUPROFEN Amazon.com Services LLC d53cb3f1-6689-40dd-bdea-fad3a841d482 2020-09-03 Warnings Name fallback generic name: IBUPROFEN Dolex Children IBUPROFEN Pharmadel LLC ac3c264f-da37-a474-e053-2a95a90abdad 2020-08-06 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN Bryant Ranch Prepack 6d189e86-4c36-43f5-b406-a342458d4155 2020-05-27 Name fallback brand name: IBUPROFEN generic name: IBUPROFEN childrens ibuprofen IBUPROFEN Rite Aid Corporation af68a4bf-bc49-40c7-812d-035eff474ed9 2020-04-03 Warnings Name fallback generic name: IBUPROFEN JUNIOR STRENGTH ADVIL IBUPROFEN Proficient Rx LP 91fc4794-1880-460f-86dd-49d8c1e872bc 2020-03-01 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN Proficient Rx LP 6d84ed87-b643-46e2-96d4-2052f41bd936 2020-02-01 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PURACAP PHARMACEUTICAL LLC 9e86b6e5-5374-4699-a0d1-a4c3d069f262 2020-01-17 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN childrens ibuprofen IBUPROFEN H E B e7e2b766-6d05-49e2-9e88-72454b857935 2019-12-27 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN PuraCap Pharmaceutical LLC 73eb763e-ce21-4cff-854f-3297f20f1f61 2019-12-10 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PuraCap Pharmaceutical LLC 40501966-419a-4ccd-b7c9-5581cbe47a97 2019-12-10 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN PuraCap Pharmaceutical LLC b6e14f73-1f19-4cfa-8858-136a38ee32d0 2019-12-10 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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 48792-7811 Ibuprofen Ibuprofen Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7812 Ibuprofen Ibuprofen Sunshine Lake Pharma Co., Ltd. ANDA Current 48792-7813 Ibuprofen Ibuprofen Sunshine Lake Pharma Co., Ltd. ANDA Current