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 25 of 48 · 948 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Topcare ibuprofen IBUPROFEN Topco Associates LLC 479a0c97-dbd9-47ad-9910-9dd4edf5136f 2025-07-02 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN CVS Pharmacy e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c 2025-07-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 37eaa3b1-98e9-4fcf-ae74-153bfc35551f 2025-07-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 7b2f7a68-8f5e-a340-e053-2991aa0a5aeb 2025-07-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 8fecb3a8-d288-cacf-e053-2a95a90ae238 2025-07-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 8fed1f86-49a0-4747-e053-2a95a90a42b8 2025-07-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Chain Drug Consortium, LLC f0f01b97-e52c-4077-a4c6-c59736f4c171 2025-06-30 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Aphena Pharma Solutions - Tennessee, LLC 388e68dc-1822-f375-e063-6294a90a3d41 2025-06-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN JUNIOR STRENGTH ADVIL IBUPROFEN Haleon US Holdings LLC 07d4c400-b182-92f7-7574-9e0e94c39cce 2025-06-27 Warnings Name fallback generic name: IBUPROFEN leader Ibuprofen IBUPROFEN Cardinal Health 110, LLC. dba Leader 009dde4c-d944-4206-8c9f-35bc8fd92715 2025-06-26 Warnings Name fallback generic name: IBUPROFEN Ibuprofen Childrens IBUPROFEN Kroger Company 47a3b118-614d-405d-b80e-31f0b354c430 2025-06-25 Warnings Name fallback generic name: IBUPROFEN Good Neighbor Pharmacy Childrens Ibuprofen IBUPROFEN Amerisource Bergen 40a6a842-a85b-4e24-8786-32ecd74f6870 2025-06-25 Warnings Name fallback generic name: IBUPROFEN Childrens Ibuprofen IBUPROFEN Safeway 1b7854d6-32b9-4410-bb40-0f02e46c7966 2025-06-24 Warnings Name fallback generic name: IBUPROFEN Motrin IB IBUPROFEN Morning Star OTC e69f00c4-b8ec-4a83-9eea-8cb2835ad776 2025-06-19 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN AAA Pharmaceutical, Inc. 1e686091-6456-36c8-e063-6294a90a3866 2025-06-17 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Ibuprofen IBUPROFEN AAA Pharmaceutical, Inc. 78cf5df8-392b-4a4e-b424-af765a6defdf 2025-06-17 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN FSA STORE INC. ec6b015d-e72e-89c4-e053-2a95a90af81c 2025-06-17 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Topcare Ibuprofen IBUPROFEN Topco Associates LLC 8be375b0-c729-49de-abc5-2e7d37144b89 2025-06-16 Warnings Name fallback generic name: IBUPROFEN good neighbor pharmacy ibuprofen IBUPROFEN Amerisource Bergen 08d9477e-3033-4b74-8f81-934f39e37e55 2025-06-16 Warnings Name fallback generic name: IBUPROFEN equaline ibuprofen IBUPROFEN United Natural Foods, Inc. dba UNFI 9bf3546a-9f94-47b5-9b01-aed93e69d5aa 2025-06-16 Warnings Name fallback 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