Home Applications 207052 Application 207052
Type ANDA
Sponsor STRIDES PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBUPROFEN IBUPROFEN TABLET;ORAL 200MG 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 A207052-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2017-05-30
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 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207052-001 IBUPROFEN 200MG TABLET / ORAL 2017-05-30 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 14 of 47 · 926 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN L.N.K. International, Inc. d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c 2026-01-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Meijer Distribution Inc c0c64ba5-b6b0-4221-9e44-110d92c93782 2026-01-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Coupler LLC 4831785a-cde2-79a2-e063-6294a90a9a40 2026-01-12 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN L.N.K. International, Inc. c93da67f-f42e-4baa-976b-73c71ba6dd71 2026-01-12 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN GOOD SENSE CHILDRENS IBUPROFEN IBUPROFEN L. Perrigo Company cd06ffc5-4921-4b2d-88ea-939fa4daf59c 2026-01-09 Warnings Name fallback generic name: IBUPROFEN Xpect Ibuprofen IBUPROFEN Cintas Corporation 976ba88a-6428-40d1-a2fd-eac64963ba1d 2026-01-08 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN Strides Pharma Inc 69b208ff-83f5-40d1-a2ff-d54b390e46e4 2026-01-08 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN ibuprofen IBUPROFEN CVS Pharmacy ace493e6-91bc-41aa-8e5c-5bc14981de91 2026-01-06 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Ibuprofen minis IBUPROFEN Safeway, Inc. 22927a12-6837-4d57-8e60-043000f2f208 2026-01-05 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN DOLGENCORP, LLC 37ccb303-c70e-48b3-a8a3-2b0097cf8f88 2026-01-05 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN DG Health Ibuprofen IBUPROFEN Dolgencorp Inc 1dd4ffc5-3132-419b-8e70-78a7bb71da62 2026-01-02 Warnings Name fallback generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC 2f12a20c-4293-d18a-e063-6294a90a3afc 2026-01-02 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC c20f1f4d-59b3-6bbe-e053-2a95a90abaf1 2026-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC ab313564-27dc-0297-e053-2a95a90a6690 2026-01-01 Warnings Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC dac07d8f-6b6f-20ab-e053-2a95a90af3ba 2026-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN Ibuprofen IBUPROFEN Northwind Health Company, LLC da6c72ad-009f-3d7f-e053-2995a90a68e9 2026-01-01 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Ibuprofen generic name: IBUPROFEN ibuprofen IBUPROFEN Northwind Health Company, LLC da6c2802-5d15-dbcb-e053-2a95a90a2561 2026-01-01 Warnings Name fallback brand name: ibuprofen generic name: IBUPROFEN Motrin IB IBUPROFEN Savings Distributors LLC 56846774-8413-c306-e063-6394a90a2be8 2026-01-01 Warnings Name fallback generic name: IBUPROFEN IBUPROFEN IBUPROFEN TIME CAP LABORATORIES, INC e0a8315a-80a5-4be3-aad1-3d01f00df494 2025-12-29 Warnings Name fallback brand name: IBUPROFEN generic name: IBUPROFEN Childrens Ibuprofen Oral Suspension Original Berry Flavor IBUPROFEN Puro Pharma Inc. 6b993b25-9c81-4d75-b332-6de3f6c3b4c9 2025-12-27 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59556-805 IBUPROFEN IBUPROFEN Strides Pharma Inc. ANDA Current 59556-806 IBUPROFEN IBUPROFEN Strides Pharma Inc. ANDA Current 72927-805 IBUPROFEN IBUPROFEN Strides Consumer LLC ANDA Current 72927-805 IBUPROFEN IBUPROFEN Strides Consumer LLC ANDA Current