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 13 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Major Pharmaceuticals 42b6faf5-ef47-6a7a-e063-6394a90ac409 2026-02-05 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN HyVee Inc 4c24c884-55f7-40b4-8d6f-db6144d5ebcb 2026-02-05 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN CareOne Ibuprofen IBUPROFEN American Sales Company 03cdff8a-8890-440d-82b5-54ce809f88cc 2026-02-03 Warnings Name fallback generic name: IBUPROFEN Pain Relief Ibuprofen IBUPROFEN Rite Aid Corporation c85c3d1f-7639-4cfa-bf3a-424b61757b1a 2026-02-03 Warnings Name fallback generic name: IBUPROFEN ibuprofen IBUPROFEN HyVee Inc 5233c409-3743-4312-9f75-14ded6755b5c 2026-02-02 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN pain relief ibuprofen IBUPROFEN Rite Aid Corporation 2bd1438e-27b1-81ff-f8e1-0f5b50b04581 2026-02-02 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. 8b5eec38-bdf3-4f27-802f-f4c732ae5c7d 2026-02-02 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN H E B 88c7486b-f9a7-4856-a25a-7c06e1382f1a 2026-02-02 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Strategic Sourcing Services, LLC dc469eb2-89cc-46c9-9304-f6cf119c0570 2026-01-29 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Caldolor IBUPROFEN Cumberland Pharmaceuticals Inc. 1eaa7790-f1a1-4f51-b10a-cbbaf033f684 2026-01-29 Boxed warning, Warnings, Adverse reactions Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Softgel Healthcare Private Limited 2b07ace6-6766-0a06-e063-6294a90ad1bd 2026-01-27 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Major Pharmaceuticals 847758ed-66fc-4db9-8fdb-78f3c3291a03 2026-01-26 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN CVS Pharmacy 8d9f11a5-ca98-4280-9c6a-093d32e60ace 2026-01-22 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN equate ibuprofen IBUPROFEN Wal-Mart Stores Inc b29034a6-657b-426f-a41a-5e64c4bc759d 2026-01-20 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Preferred Pharmaceuticals Inc. 70e191ef-8fad-49eb-9850-fceea119e92f 2026-01-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Preferred Pharmaceuticals Inc. b84ea215-e61d-4c00-8a34-d47c4080779b 2026-01-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN WALGREENS 40a1e525-fb1e-08f4-e063-6294a90adfa7 2026-01-14 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. 82e907e6-86a9-5c7f-93bd-a6319d74100f 2026-01-13 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN HYVEE INC 45aead8a-37ee-9a66-e063-6394a90a5d17 2026-01-13 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN HYVEE INC 459fc063-0664-09b7-e063-6394a90a89e0 2026-01-13 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